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

Model Number	ZCT300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Halo (2227); No Code Available (3191)
Date of Event	12/14/2016
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 mechanical failure.Further information was provided and stated that mechanical failure refers to halos/glare and blurry vision and that it is unknown if it's due to the lens or due to a patient issue.A vitrectomy was performed.No further information was provided.
Additional Manufacturer Narrative
Corrected data: in review of the initial mdr, it was noted that vitrectomy was performed.Device evaluation: the intraocular lens (iol) was returned to the manufacturing site for investigation.Visual inspection of the lens using 12x magnification shows no anomalies were found.The condition of the lens is consistent to a used and explanted product.The customer's reported event could not be confirmed.Manufacturing record review: a review of the manufacturing records was performed.The product was manufactured according to specification.A search of complaints revealed that no similar complaints were received for this production order number.Labeling evaluation: the directions for use (dfu) was reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the intraocular lens.Based on the results of the investigation, no quality product deficiency was identified.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6306010
• Report Number: 9614546-2017-00081
• Device Sequence Number: 512986
• Product Code: HQL
• UDI-Device Identifier: 05050474553330
• UDI-Public: (01)05050474553330(17)200501
• 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,Followup
• Report Date (Section B): 03/24/2017

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: 05/01/2020
• Device Model Number: ZCT300
• Device Catalogue Number: ZCT300U205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/12/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2017
• Supplement Report FDA Received Date: 03/24/2017
• 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: 81 YR