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 Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was explanted and replaced due to refractive surprise with iol rotation in the right eye.The degree of rotation was not provided.There was no need for incision enlargement, vitrectomy, or sutures.There was no patient injury.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
During follow-up, additional information was received as follows: there was a 14-degree misalignment.The physician went straight to explant due to spherical equivalent error on the calculator.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Device available for evaluation? yes, returned to manufacturer on 8/11/2017.Device returned to manufacturer? yes.The product was received for investigation and visually inspected.Visual inspection with the unaided eye shows the product was cut in pieces, most probably to make explant possible.Considering the condition of the lens additional analysis was not possible.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.The directions for use (dfu) were reviewed.The dfu provide the customer with proper usage instructions and guidelines.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: 6793536
• Report Number: 9614546-2017-00744
• Device Sequence Number: 1541150
• Product Code: HQL
• UDI-Device Identifier: 05050474553224
• UDI-Public: (01)05050474553224(17)190803
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2017

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: 08/03/2019
• Device Model Number: ZCT300
• Device Catalogue Number: ZCT300U150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2017
• Initial Date Received by Manufacturer: 07/20/2017
• Supplement Date Received by Manufacturer: 08/22/2017; 09/11/2017
• Initial Report FDA Received Date: 08/14/2017
• Supplement Report FDA Received Date: 09/14/2017; 10/04/2017
• 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
• Patient Age: 76 YR