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 Code	No Code Available (3191)
Date of Event	08/22/2016
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) lens was implanted but the doctor changed diopter and the lens was explanted.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: the intraocular lens (iol) was not retuned to the manufacturing site.Without the return of the lens, the customer's reported event could not be confirmed.Manufacturing record review: a review of the manufacturing records was performed.There were no deviations identified that were related to the event in the production order.There were no non conformances identified in the review.The product was manufactured according to specification.The complaint related test is the optical measurement performed at final inspection.The in-line optical inspection data shows the lens was within specification in terms of optical and cylinder power.A search on complaints revealed that no other complaints for this order number were received to date.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.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: TORIC IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 5954887
• Report Number: 9614546-2016-00464
• Device Sequence Number: 1136536
• Product Code: HQL
• UDI-Device Identifier: 05050474553323
• UDI-Public: (01)05050474553323(17)190723
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• 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): 10/18/2016

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: 07/23/2019
• Device Model Number: ZCT300
• Device Catalogue Number: ZCT300U200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2016
• Supplement Report FDA Received Date: 10/19/2016
• 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