MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS CL; MONOFOCAL IOLS

Model Number	Z9002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluation: complaint device was returned for evaluation.Visual inspection at 10x microscope magnification was performed.The lens was observed cut in half.The condition observed is consistent with a lens that has been cut due to lens removal or explant procedure.During sample evaluation, the piece of lens was observed clear as expected.The reported issues could not be verified.The lens returned cut making it difficult to inspect the optic zone.The reported complaint was not confirmed.The manufacturing production order (po) was evaluated and the devices were manufactured within specifications.The units were released according to specification.During manufacturing process, all lenses are inspected under 10x microscope magnification and defective devices are rejected.A review of the complaints related to the production order was performed and the results revealed no other complaints for this order number.A historical complaint data review was performed and results did not identify any product deficiency.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 manufacturing record review, returned device analysis and labeling review, there is no indication of a product malfunction or product quality deficiency.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a patient experienced hyperopic refractive surprise after implantation of a 16.5 diopter z9002 intraocular lens (iol).The lens was explanted and replaced with a 21.0 diopter z9002 iol.There was no incision enlargement, no vitrectomy, no sutures or other patient injury.No further information was provided.

• Brand Name: TECNIS CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 5905702
• Report Number: 2648035-2016-01343
• Device Sequence Number: 10863526
• Product Code: HQL
• UDI-Device Identifier: 05050474530621
• UDI-Public: (01)05050474530621(17)210219
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• 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): 08/25/2016

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: 02/19/2021
• Device Model Number: Z9002
• Device Catalogue Number: Z900200165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2016
• Initial Report FDA Received Date: 08/26/2016
• 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: 67 YR