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	Visual Impairment (2138); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown/ not provided.Date of event: unknown, not provided.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that model zxt150 tecnis symfony toric multifocal iol (intraocular lens) was to be explanted on (b)(6) 2018 from patient's eye.The reason for the explant is unknown, not provided.No additional information provided.
Additional Manufacturer Narrative
Based on new information received, patient was unhappy with her vision, so iol had to be explanted.Furthermore, patient stated poor visual quality with specialty implant.Patient 1-week post-op was 20/30 in dv (distant vision).There was no enlargement of incision and there was no vitrectomy required.The following sections have been updated accordingly: age/date of birth: 68 years old.Device available for evaluation? yes.Returned to manufacturer on: 10/16/2018.Device returned to manufacturer? yes.(b)(4).The product was received dry in a jar.Visual inspection with the unaided eye shows the product is cut in pieces, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.The complaint cannot be confirmed.The manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.There was no discrepancy found during the mrr (manufacturing record review).The product was manufactured and released according to specifications.A search revealed that no similar complaints were received for this production order.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are (b)(4) and capa-010215.

• Brand Name: TECNIS SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7950252
• Report Number: 9614546-2018-00954
• Device Sequence Number: 2337433
• Product Code: POE
• UDI-Device Identifier: 05050474605206
• UDI-Public: (01)05050474605206(17)220223
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2020
• Report Date (Section F): 01/01/2005

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: 02/23/2022
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 10/16/2018; 10/25/2020
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 11/09/2018; 11/03/2020
• 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: Required Intervention
• Patient Age: 68 YR
• Date Report Sent to FDA: 01/01/2005