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	12/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable as there is no indication that the lens was explanted.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a toric intraocular lens (iol) was implanted in the right eye of a (b)(6) male patient on (b)(6) 2017.The lens originally placed at 110 degrees, was measured at 160 degrees on (b)(6) 2017.Additional information was received and it was learnt that the lens was repositioned on (b)(6) 2018.No complications were reported; a vitrectomy was not performed and sutures were not used.The patient was discharged without complications.No further information was provided.
Additional Manufacturer Narrative
Additional information per follow-up on 01/24/2018 reported an iol rotation from 110 degrees to 120 degrees.Subject experienced a previous iol rotation of 50 degrees and underwent iol repositioning on (b)(6) 2018, during which the iol was placed at the intended axis of 110 degrees.At a follow-up visit on (b)(6) 2018, the iol was observed at to be at 120 degrees, which is a 10 degree difference.No additional repositioning is planned.Procedure was completed successfully.Patient has recovered.Device evaluation: the product testing could not be performed as the complaint device was not returned as it remains implanted.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during the review related to the complaint issue reported.There was no discrepancy found during the mrr (manufacturing record review).The product was manufactured and released according to the specifications.The search of complaints revealed no similar complaints for this production order.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 7201497
• Report Number: 9614546-2018-00066
• Device Sequence Number: 13772285
• Product Code: HQL
• UDI-Device Identifier: 05050474602694
• UDI-Public: (01)05050474602694(17)200602
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2018

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: 06/02/2020
• Device Model Number: ZCT450
• Device Catalogue Number: ZCT450U055
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/20/2017
• Supplement Date Received by Manufacturer: 01/24/2018
• Initial Report FDA Received Date: 01/17/2018
• Supplement Report FDA Received Date: 02/21/2018
• 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: 66 YR