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

Model Number	ZCT300
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/18/2017
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 remains implanted.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
The intraocular lens (iol) was noted to have rotated 14 degrees at the 6-month postoperative visit.The protocol defined slit lamp measurement was 98 degrees on (b)(6) 2017 vs.The intended operative placement of 84 degrees on (b)(6) 2016.The iol remains implanted.No repositioning or further intervention is required.No patient complications/injury.Best corrected distance visual acuity was 20/20 (od) and 20/25 (ou) on (b)(6) 2017.Outcome does not significantly interfere with activities of daily life.The patient is currently doing well.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Device evaluation: the lens remains implanted; therefore, it was not returned for investigation.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: 6704413
• Report Number: 9614546-2017-00605
• Device Sequence Number: 1243981
• Product Code: HQL
• UDI-Device Identifier: 05050474553484
• UDI-Public: (01)05050474553484(17)200425
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 04/25/2020
• Device Model Number: ZCT300
• Device Catalogue Number: ZCT300U280
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/16/2017
• Supplement Date Received by Manufacturer: 07/17/2017
• Initial Report FDA Received Date: 07/11/2017
• Supplement Report FDA Received Date: 08/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR