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

Model Number	ZA9003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was explanted due to myopia.There was no post op patient injury reported.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 10/19/2016.Returned to manufacturer: yes.Device evaluation: the intraocular lens (iol) was returned to the manufacturing site for investigation.Visual inspection at 10x microscope magnification was performed.The lens was cut in two pieces and was probably related to the explant process.Viscoelastic residue was observed on the lens pieces.A functional test could not be performed due to conditions of the returned lens.The reported complaint could not be verified.Manufacturing record review: a review of the manufacturing records was performed.There were no discrepancies found during the review.The documentation shows that the production order was manufactured according to specifications.There were no associated deviation or non-conformity reports found in the review related to this complaint.The units were released according specification in compliance with the product intended use as required.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the product.Based on the results of the investigation, no product deficiency was identified.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 5905688
• Report Number: 2648035-2016-01342
• Device Sequence Number: 16220259
• Product Code: HQL
• UDI-Device Identifier: 05050474528949
• UDI-Public: (01)05050474528949(17)201102
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2016

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: 11/02/2020
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/26/2016
• Supplement Report FDA Received Date: 11/16/2016
• 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