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

Model Number	ZCT150
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Give date: (b)(6) 2017; therefore entered (b)(6) 2017 as the best estimate.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that the lens was implanted and then explanted during a secondary surgical procedure.It was reported that the lens subluxed and fell out of place.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Device available for evaluation? yes, returned to manufacturer on 8/18/2017.Device evaluation: the sample was inspected by a qualified final inspection operator using 12x microscope magnification.It could be seen that the optic was damaged and torn.There were no further anomalies.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: 6723640
• Report Number: 9614546-2017-00635
• Device Sequence Number: 1539415
• Product Code: HQL
• UDI-Device Identifier: 05050474552166
• UDI-Public: (01)05050474552166(17)200405
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2017

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: 04/05/2020
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Initial Date Received by Manufacturer: 06/23/2017
• Supplement Date Received by Manufacturer: 10/03/2017
• Initial Report FDA Received Date: 07/18/2017
• Supplement Report FDA Received Date: 10/27/2017
• 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: Required Intervention