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

Model Number	ZCT525
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens remains implanted.(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that a zct525 30.0 diopter intraocular lens (iol) was implanted on a female patient's left eye.However, at 1 week post-op the physician noticed the lens had rotated.The lens was originally placed at 115 degrees intra-op, and the access markers were observed at 160 degrees.The physician plans to reposition the lens at 115 degrees intra-op on (b)(6) 2017.No further information was provided.
Additional Manufacturer Narrative
Additional information: the complaint reporter confirmed that the iol was successfully repositioned on (b)(6) 2017 and the patient is doing well.The following have been updated accordingly: required intervention to prevent permanent impairment/injury patient code: (b)(4) - reposition of intraocular lens in a secondary procedure.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: 6616924
• Report Number: 9614546-2017-00502
• Device Sequence Number: 979334
• Product Code: HQL
• UDI-Device Identifier: 05050474603776
• UDI-Public: (01)05050474603776(17)210512
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2017

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: 05/12/2021
• Device Model Number: ZCT525
• Device Catalogue Number: ZCT525U300
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2017
• Supplement Date Received by Manufacturer: 06/07/2017
• Initial Report FDA Received Date: 06/06/2017
• Supplement Report FDA Received Date: 06/29/2017
• 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; Required Intervention
• Patient Age: 42 YR