Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.Lot number: unknown/ not provided.Expiration date: unknown as the lot number was not provided.Unique identifier (udi#): complete udi is unknown as the lot number was not provided.If implanted, give date: not applicable as this is not an implantable device.If explanted, give date: not applicable as this is not an implantable device.Device manufacture date: unknown as the lot number was not provided.Note: two lot numbers were provided but it is unknown which one was used in this event.Lot cc04219, (b)(4).Lot cc04220, (b)(4).All pertinent information available to abbott medical optics has been submitted.
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During follow-up it was reported that a clear, film-like substance was noted on the back of the intraocular lens (iol) immediately after iol implantation in the left eye.The substance was removed with irrigation and aspiration with no other detrimental intra- or post-operative effects noted.The debris is not available for analysis.The cartridge is not available for analysis.The debris was located in the posterior aspect of the iol.The lens was prepared per the directions for use (dfu) the viscoelastic used during the surgery was amvisc plus.There was no visible damage in the cartridge after iol delivery.The lens remains implanted.No incision enlargement, no serious patient injury, no sutures, no vitrectomy.The patient outcome is good as no postoperative adverse event.(b)(6).Sex/gender: female.Lot#: cc04219.Expiration date: 4/7/2018.(b)(4).Concomitant medical products: zcb00, serial (b)(4).Device manufacture date: 4/7/2017.Device evaluation: the product was not returned for investigation.The reported complaint was not verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the product.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to abbott medical optics has been submitted.
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