The customer stated that one of their patients developed a rash to the eyes and surrounding area following an ophthalmic surgery.The component source was unknown but the customer felt it could possibly be from the transparent dressing td-24cns2 from the basic cataract pack/ sey54cpcan.The patient was treated with prednisolone acetate 1% 1gtt both eyes, topical bacitracin/polysporin and topical hydrocortisone 1% on surrounding area and oral cephalexin.The rash resolved.A sample was not received from the customer for evaluation and a review of the device history record could not be reviewed since the lot number was not provided.The component td24cns2 is a non-sterile product.The transparent dressing is intended to use on wound care application, securing objects to skin and as a secondary dressing.Six bio compatibility tests in year 2015 were conducted.There was no abnormality found on the test result.Based on the limited information available, the root cause could not be determined and no further action will be taken at this time.The complaint information was informed to the relevant sectors for their awareness and we will continue to monitor the trend of this type of incident.
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