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

Model Number	ZXT375
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The onset of the macular degeneration was not provided (2017).(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a multifocal toric intraocular lens (model zxt375, +21.5 diopter) was explanted in a secondary surgical procedure from the right eye of a (b)(6) male patient because of retina issues.Additional information was received and the account commented that there was no product quality issue.The lens was explanted because the patient had acute onset of macular degeneration.The incision was enlarged to removed the lens and sutures were used.No vitrectomy was performed and no serious patient injury was reported.A monofocal lens (model z9002, +21.0 diopter) was implanted as a replacement.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: the intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection at 12x microscope magnification showed that the product was damaged, most probably to make the explant possible.The condition of the return sample do not suggest that the damage was introduced during manufacturing.The customer's reported complaint could not be verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no similar complaints for this order number have been received.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6892936
• Report Number: 9614546-2017-00924
• Device Sequence Number: 13612430
• Product Code: POE
• UDI-Device Identifier: 05050474607002
• UDI-Public: (01)05050474607002(17)211108
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2017

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?: No
• Operator of Device: Physician
• Device Expiration Date: 11/08/2021
• Device Model Number: ZXT375
• Device Catalogue Number: ZXT375U215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Initial Date Received by Manufacturer: 08/31/2017
• Supplement Date Received by Manufacturer: 10/13/2017
• Initial Report FDA Received Date: 09/26/2017
• Supplement Report FDA Received Date: 11/08/2017
• 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: 66 YR