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

Model Number	ZCT400
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It was reported that the patient had an intraocular lens (iol) implanted in the right eye on (b)(6)2017, where the iol was placed at 118 degrees.The patient returned on (b)(6) 2017, for the 1-month post-operative exam, and the iol had rotated and was at 104 degrees.The subject was reported to be happy with their visual outcome.No repositioning is planned.Uncorrected visual acuity -right eye = 20/25.Best corrected visual acuity- right eye = 20/20.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: 7047400
• Report Number: 9614546-2017-01137
• Device Sequence Number: 1256416
• Product Code: HQL
• UDI-Device Identifier: 05050474553859
• UDI-Public: (01)05050474553859(17)210418
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2017

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: 04/18/2021
• Device Model Number: ZCT400
• Device Catalogue Number: ZCT400U170
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/24/2017
• Supplement Date Received by Manufacturer: 11/21/2017
• Initial Report FDA Received Date: 11/20/2017
• Supplement Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR