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of corneal opacities. We raise a specific issue that may 2 United States Food and Drug Administration. VisionBlue limit the benefits of this technique. (trypan blue ophthalmic solution) product label. Available at: An 83-year-old Caucasian female with visual acuity of http://www.fda.gov/cder/foi/label/2004/0216701lbl.pdf. 3 Bhartiya P, Sharma N, Ray M, Vajpayee RB. Trypan blue 6/60 consented for left cataract extraction and lens assisted phacoemulsification in corneal opacities. Br J implant. She had a history of left herpes zoster Ophthalmol 2002; 86: 857–859. ophthalmicus, with secondary keratouveitis. Her left 4 Jacobs DS, Cox TA, Wagoner MD, Ariyasu RG, Karp CL. corneal sensitivity was reduced and she had diffuse Capsule staining as an adjunt to cataract surgery. stromal scarring. Severe superficial punctate keratitis Ophthalmology 2006; 113: 707–713. 5 Norn MS. Postmortal ‘‘vital’’ staining of the external eye. persisted following maximisation of her topical Acta Ophthalmol (Copenh) 1979; 57(2): 292–304. lubricants. We were advised by the Corneal subspecialist that the cornea was unlikely to improve any further. ME Gregory and K Bibby A guarded visual prognosis was explained to the patient. Trypan blue 0.06% was employed to enhance Department of Ophthalmogy, Leicester Royal visualisation of the capsule; the dye was injected onto the Infirmary, Leicester, UK anterior lens capsule under an air bubble. Following wash out of the dye with balanced salt solution, diffuse Correspondence: uptake of the dye by the corneal epithelium was noted. ME Gregory, Although the stained anterior capsule was more visible Ophthalmology Department, and continuous curvilinear capsulorrhexis facilitated, Windsor Building, visualisation of the whole procedure was significantly Leicester Royal Infirmary, reduced by the diffuse staining of the corneal epithelium Infirmary Square, with trypan blue. Leicester LE1 5WW, UK Trypan blue selectively stains connective tissue Tel: þ 44 116 224 5159; 2 structures in the human eye. It is commonly used during Fax: þ 44 116 258 5927. cataract extraction, to aid capsulorrhexis in mature, E-mail: [email protected] traumatic, or white cataracts, when the red reflex is 3,4 5 absent. Norn studied vital staining in cadaveric eyes Proprietary interests: none declared in the first 46 h after death, showing that Trypan blue Research funding: no funding obtained staining of the cornea increased progressively, demonstrating that loss of epithelial integrity through cell death resulted in corresponding corneal staining. Eye (2007) 21, 299–300. doi:10.1038/sj.eye.6702556; In cases where corneal opacification is not extensive published online 1 September 2006 enough to justify the use of a corneal triple procedure, the use of trypan blue significantly facilitates cataract extraction. However, caution must be employed in the presence of corneal epithelial breakdown. Efforts should Sir, be made to reduce staining of the epithelium with trypan Reply to Dr Gregory and Dr Bibby blue. The application of viscoelastic to the surface of the cornea before anterior chamber washout reduces contact We would like to thank Dr Gregory and Dr Bibby for the of trypan blue with the corneal epithelium. The quantity valuable inputs from their side in order to make the of dye used can be reduced by instilling one or two drops technique of dye-assisted small incision cataract surgery of the dye directly onto the anterior lens capsule under more effective in eyes with corneal opacity. viscoelastic rather than an air bubble.3 Persistent severe superficial punctate keratitis in We hope these practical hints will enhance the benefit an eye means that the ocular surface is not stable. No of the technique described by Titiyal et al when surgery is acceptable in such a situation. This eye performing SICS in patients with coexisting corneal requires intensive preservative-free lubricant drops and opacities and epithelial disease. gel and, if needed, an amniotic membrane graft. Cataract surgery should be performed only when the ocular surface becomes stable. However, if the ocular surface does not improve despite all efforts and cataract surgery References is very essential for the patient owing to visual handicap or maturity of the cataract as was the present case, care 1 Titiyal JS, Sinha R, Sharma, Vajpayee RB. Dye-assisted small incision cataract surgery in eyes with cataract and coexisting should be taken while injecting the trypan blue dye for corneal opacity. Eye 2006; 20: 386–388. staining the anterior capsule. A small amount of dye

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should be directly applied onto the anterior capsule, so legislation covering these activities. A full Quality that there is minimal extra dye in the anterior chamber Assurance Inspection of each batch is conducted by the thereby preventing a large spill over during dye washout. manufacturing facility before release of the product to the This is a sort of painting the anterior capsule. We do it market, and extreme care is taken in every stage of the under the air bubble, however, as suggested it can be distribution chain to ensure that product is delivered to a performed under viscoelastic to prevent further spill over. customer in the best possible condition. There was an uptake of trypan blue dye by the corneal Alcon, as manufacturer was notified of this complaint epithelium because of the presence of severe punctate on the 27th November 2002. Although the complaint keratitis in the present case. To avoid this, it is a novel sample was not returned for evaluation and confirmation idea to put viscoelastic over the corneal epithelium of the defect, Alcon immediately performed a full and before dye washout. We prefer keeping a layer of thorough investigation using the information available at viscoelastic on wet cornea throughout the procedure the time, the results of which are listed below. instead of continuously wetting the cornea with saline There were 17 500 other units manufactured in this lot, even in eyes with stable ocular surface as it also improves and review of our complaint records showed that there visualization. We did not mention this point in the paper were no other reported or associated incidents with any by mistake and it has been rightly pointed out by other unit in this lot. Dr Gregory and Dr Bibby and we fully agree with them. As additional assurance, we also reviewed the Postoperatively, these patients should be put on manufacturing batch records for this lot, which found no intensive lubricants and less frequent topical steroids in sterility problems associated with its production; and order to minimize drug-related epithelial toxicity and inspected retention samples, which showed no evidence corneal melting. of fungal growth. The directions for use associated with this product, JS Titiyal, R Sinha, N Sharma and RB Vajpayee recommend ‘Do not use unless product is clear, seal is intact, vacuum is present and the container is undamaged’. Rajendra Prasad Centre for Ophthalmic Sciences, As the author reports ‘ya hairline crack measuring 6.5 cm All India Institute of Medical Sciences (AIIMS), 492, in circumference was notedy’. This emphasises the need, R.P. Centre, Ansari Nagar, New Delhi, as pointed out in the letter, to visually inspect all products Delhi 110029, India supplied before use to ensure that nothing untoward has happened during transportation. Correspondence: JS Titiyal, The sentence ‘The supplier was notified and all bottles Tel: þ 91 11 26593146; of BSS from the same batch were recalled’ is not correct. Fax: þ 91 11 26588919. There was no ‘product recall’ associated with this product E-mail: [email protected] as the tests reported above showed no other defects. The hospital voluntarily exchanged all other units of this lot number held by them, and were provided with Eye (2007) 21, 300–301. doi:10.1038/sj.eye.6702557; replacement units with a different lot number the next day. published online 1 September 2006 We would appreciate your help in ensuring that this information is brought to the attention of your readers.

Sir, N Smith Alcon response to BSS article Alcon Laboratories UK Limited, Pentagon Park, We have read with interest the article published in a recent Boundary Way, Hemel Hempstead, Hertfordshire version of ‘Eye’ regarding ‘A Fungal ball in the irrigating Hp2 7UD, UK solutions during phacoemulsification’ which makes reference to Alcon’s 500 ml Balanced Salt Solution (BSS), Correspondence: N Smith, and would like the chance to both comment on the article Tel: þ 44 1442 341234; and to correct some information contained within it. Fax: þ 44 1442 341280. Alcon would like to emphasise their total commitment E-mail: [email protected] to the production of high-quality products. Alcon’s products are produced under strictly controlled and Eye (2007) 21, 301. doi:10.1038/sj.eye.6702564; inspected conditions, and all manufacturing sites adhere published online 25 August 2006 to the principles of Good Manufacturing and Distribution Practice (GMP/GDP), as well as to any additional local

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