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

Model Number	ZCT300
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Flashers (1864); Visual Disturbances (2140)
Date of Event	02/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of birth: unknown/ not provided.If explanted; give date: n/a (not applicable).The intraocular lens was not explanted.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that there was a misalignment of 11 degrees between operative and the 4 month postoperative visit.The intraocular lens (iol) was placed at 76 degrees in the right eye during the initial surgery ((b)(6) 2016) and was measured at the 4 month visit (16 feb 2017) to be at 65 degrees, with a difference of 11 degrees.The patient complained of flashes of light and haziness in the right eye.No other patient complications and/or related injuries.The iol remains implanted.No repositioning was required.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Device evaluation: product testing could not be performed because the product was not returned.The reported complaint was not verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no similar complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The dfu provide the customer with proper usage instructions and guidelines.Conclusion: as a result of the investigation, 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: 6426842
• Report Number: 9614546-2017-00226
• Device Sequence Number: 454901
• Product Code: HQL
• UDI-Device Identifier: 05050474553149
• UDI-Public: (01)05050474553149(17)191223
• 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: health professional,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2017

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 12/23/2019
• Device Model Number: ZCT300
• Device Catalogue Number: ZCT300U110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/23/2017
• Supplement Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 03/23/2017
• Supplement Report FDA Received Date: 08/30/2017
• 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: Other
• Patient Age: 66 YR