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

Model Number	ZCT450
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/22/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted; give date: na (not applicable) to date, the intraocular lens remains implanted.(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 implanted on (b)(6) 2016.The lens rotated off intended axis.The surgeon plans to take patient back to the operating room next week to correct.Further information was provided and indicated the degree of rotation was 21 degrees.There was no injury during surgery.During the postop period patient developed a large cornea epithelial defect which is not healing and the doctor has decided to hold off on repositioning of the lens until the patient's eye heals completely.No further information was provided.
Additional Manufacturer Narrative
Additional information: through follow up additional information was provided.The post implant rotation was performed on (b)(6) 2016 and it went really well.There were no complications.The patient¿s recent post-op vision was 20/30.Device evaluation the lens was not returned to the manufacturer for evaluation.Visual inspection could not be performed as the lens remains implanted, 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.There were no associated nonconformity reports or deviations.The lenses were released according to specifications.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the intraocular lenses.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: 5920048
• Report Number: 9614546-2016-00431
• Device Sequence Number: 878806
• Product Code: HQL
• UDI-Device Identifier: 05050474603011
• UDI-Public: (01)05050474603011(17)201111
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2016

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 11/11/2020
• Device Model Number: ZCT450
• Device Catalogue Number: ZCT450U215
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/01/2016
• Supplement Report FDA Received Date: 10/03/2016
• 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: 79 YR