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

Model Number	ZCT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Discomfort (2330)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no indication at the time of this report that the lens has been explanted.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that after implantation of a zct150 intraocular lens (iol) in both eyes, the patient experienced great deal of trouble under fluorescent lighting.Patient is having hard time working on the computer, is uncomfortable and has trouble seeing, focusing, completing work but is fine outside.Per the patient according to her doctor, her eyes are healthy and seeing properly.This report represents the lens implanted in patient's right eye.A separate report is being filed for the lens implanted in patient's left eye.
Additional Manufacturer Narrative
Device evaluation: the lens was not returned to the manufacturer for evaluation.Visual inspection could not be performed, therefore the reported complaint could not be verified.Manufacturing records were reviewed and the lens was manufactured according to specification.There were no non-conformances with respect to the manufacturing process.The lenses were released according to specifications.A search on complaints related to this production order was conducted.Results revealed no other complaints for this order number were received to date.Based on the investigation results there is no indication of a product quality deficiency.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: 5941108
• Report Number: 9614546-2016-00446
• Device Sequence Number: 16490716
• Product Code: HQL
• UDI-Device Identifier: 05050474552142
• UDI-Public: (01)05050474552142(17)190810
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2016

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: 08/10/2019
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/09/2016
• Supplement Report FDA Received Date: 10/11/2016
• 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: Other