Evaluation summary: the product was returned for analysis and damage was observed to the lens.Additional observations were as follows: iol returned pressed down into well area of iol case base, resulting in deformation of the iol.A significant amount of solution is dried on both surfaces of the optic and haptics.Both haptics are adhered to the optic surface in a folded position with solution.The optic is cracked/fractured.The optic is also bent/deformed.We are unable to determine the root cause for the reported complaint.The returned iol shows evidence of possible handling by the customer due to the presence of a significant amount of solution dried on both surfaces of the optic and haptics.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed lens damage would not meet our current release criteria.Based on these investigation findings, we are unable to verify that the damage was present when opened and if the iol contributed to the event.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).
|