(b)(4). If implanted, if explanted, give date: not applicable as lens was removed/replaced within the same surgery. Device evaluation: the original folding carton and directions for use were received. Visual inspection under magnification revealed viscoelastic residue on the optic body and haptics. The lens was received cut in half, which is consistent with a lens that was handled during explant. Based on the return condition of the lens no product evaluation could be performed. The complaint issue could not be confirmed, and no product deficiency was identified. Manufacturing record review: the manufacturing records for the product were reviewed. The product was manufactured and released according to specifications. The complaint search found 1 report but it's not related to the reported event. Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
It was reported that a zcb00 iol 30. 5 diopter was inserted into the patient? S operative eye. After insertion the doctor noticed a tear in the lens. The iol was removed and replaced during the same procedure with the same model. The incision was enlarged. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5