MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS 1-PIECE; MONOFOCAL IOLS

Model Number	ZCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Date of Event	06/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluation: according to the visual inspection performed on the returned lens using microscope magnification, loose particles or fibers were observed on the lens compatibles with handling the unit out of the sterile environment.Viscoelastic residues were detected on the lens optic body.The condition observed is consistent with a lens that has been handled and prepared for surgical use.No manufacturing defects were observed on the returned lens.The lens optic zone was observed clear as expected in the acrylic tecnis monofocal intraocular lens.The reported issue was not verified on the returned product.A manufacturing record review was performed; no associated deviation or non-conformity report (ncr) was generated during the manufacturing process.The product was manufactured and released according to specifications.A search on complaints related to this production order (po) was conducted.The search resulted in no other complaints were received for this po.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Based on the results of the investigation there is no indication of a product quality deficiency.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zcb00 intraocular lens (iol) was explanted in a secondary surgery from a female patient's right (od) eye.The patient had difficulties with lens (blurry vision which got worse) post implant.There was no incision enlargement, vitrectomy, or sutures required at explant and no patient injury post-op was reported.No further information was provided.

• Brand Name: TECNIS 1-PIECE
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 5944885
• Report Number: 2648035-2016-01441
• Device Sequence Number: 915589
• Product Code: HQL
• UDI-Device Identifier: 05050474531857
• UDI-Public: (01)05050474531857(17)200115
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 01/15/2020
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2016
• Initial Report FDA Received Date: 09/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR