MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS SYMFONY TORIC; MULTIFOCAL IOLS

Model Number	ZXT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: exact date unknown, not provided, best estimate is within the week of surgery (b)(6) 2020) - (b)(6) 2020.If explanted, give date: not applicable, as the lens remains implanted.All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that a female patient who was implanted with a tecnis symfony toric intraocular lens (iol) is experiencing a lack of clear vision.It was indicated that the patient is a dental assistant, unable to see to work and driving is challenging for the patient.It was noted that the lens was scheduled to be explanted on (b)(6) 2020.No further information was provided.
Additional Manufacturer Narrative
Additional information: additional information indicated that the lens was explanted as scheduled on 09/28/2020.That the affected eye was the right eye (od) and the replacement lens used was a monofocal type.There was no surgical interventions such as vitrectomy, incision enlargement or sutures required.The patient outcome was reported to be good and there was no patient injury.The account did not know if the lens was returned or not.The following fields were updated accordingly: section d7: if explanted, give date: (b)(6) 2020 section h6: patient code: 3191 - explant.Device evaluation: the product testing could not be performed as the product was not returned for evaluation.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated, and no deviation or nonconformance was found during process related to the complaint issue reported.The product was manufactured and released according to specifications.A search in complaint system was conducted and revealed that one additional complaint was received from this production order number, but is not related to this event, and no product quality deficiency was identified.Conclusion: 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 johnson and johnson surgical vision has been submitted.

• Brand Name: TECNIS SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10731227
• Report Number: 9614546-2020-00458
• Device Sequence Number: 14323475
• Product Code: POE
• UDI-Device Identifier: 05050474605312
• UDI-Public: (01)05050474605312(17)231120
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2020

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: Health Professional
• Device Expiration Date: 11/20/2023
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U255
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 11/16/2020
• 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: Other