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 Code	Vitrectomy (2643)
Date of Event	02/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted; give date: not applicable as the lens was inserted and removed.If explanted; give date: not applicable as the lens was inserted and removed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the patient's left eye (os) had no capsular support after insertion of the zxt150 multifocal iol (intraocular lens).For this reason, the doctor had to remove the lens and implant a non-johnson & johnson lens as a replacement.It was also noted that a vitrectomy was performed.The patient was reported being well post-op.No additional information was provided.
Additional Manufacturer Narrative
Additional information: device available for evaluation: yes.Returned to manufacturer on: 2/28/2019.Device returned to manufacturer: yes.Device evaluation: the sample was received inside of plastic sample jar with medical gauze and kept inside a plastic resealable biohazard bag.A visual inspection of the returned lens shows it was returned wrapped in the medical gauze.The lens was cleaned with purified water and dried with compressed air to ease inspection.Further observation under magnification showed a slice cut partially through the optic body, most probably to aid in removal.No damage to the haptics was identified.The complaint event could not be confirmed.Manufacturing records review: the manufacturing records for the product was reviewed.No nonconformance reports, discrepancies or deviations were found during the manufacturing record review.The product was manufactured and released according to specification.A search on complaints revealed that no other complaints have been received for this production order number.Labeling review: the labeling review was not reviewed because limited information was received.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 & 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 nr-0148919 and capa: 010215.

• 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: 8394195
• Report Number: 3011852734-2019-00051
• Device Sequence Number: 19542874
• Product Code: POE
• UDI-Device Identifier: 05050474605152
• UDI-Public: (01)05050474605152(17)220928
• 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
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2020
• 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: 09/28/2022
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/12/2019
• Supplement Date Received by Manufacturer: 04/22/2019; 10/25/2020
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 05/20/2019; 11/10/2020
• 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: 61 YR
• Date Report Sent to FDA: 01/01/2005