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

Model Number	ZCT300
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	08/31/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable, as the lens remained implanted.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
A physician reported a zct300 toric intraocular lens had rotated 25 to 30 degrees post implant in the right eye of a female patient.At day one post-op the patient¿s uncorrected visual acuity was 20/150 and corrected visual acuity was 20/40.The lens was subsequently repositioned in a secondary surgery.In follow up it was learned the patient is doing well.
Additional Manufacturer Narrative
Section h6 of the initial report indicated a patient code (b)(4) this was entered in error.The correct patient code is (b)(4) for rotation of the lens in a secondary procedure.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Device evaluation: the device 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.There are no associated nonconformity reports or deviations.A search on complaints revealed no other complaints were received for this order number to date.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: 6024777
• Report Number: 9614546-2016-00514
• Device Sequence Number: 19057896
• Product Code: HQL
• UDI-Device Identifier: 05050474553194
• UDI-Public: (01)05050474553194(17)190421
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Followup
• Report Date (Section B): 11/18/2016

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 04/21/2019
• Device Model Number: ZCT300
• Device Catalogue Number: ZCT300U135
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/16/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/12/2016
• Supplement Report FDA Received Date: 10/13/2016; 11/18/2016
• 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: 47 YR