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

Model Number	ZXR00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Vitrectomy (2643)
Date of Event	04/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is during 2020.If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that there was significant malformation of zonules and the zxr00 model intraocular lens (iol) was cut out of the eye and there was damage to the eye.Additional details from follow up states that malformation of the zonules was a pre-existing condition of the patient which wasn't caused by the lens.Damage to the eye was capsule tear and anterior vitrectomy was required.The procedure was completed using secondary iol.Patient was doing good at the time of discharge.No further information provided.
Additional Manufacturer Narrative
Additional information and corrected data: received stated that the initial surgery date is (b)(6) 2019 and the date that the patient returned to have the iol implanted was on (b)(6) 2019.Iol that was implanted was not a johnson and johnson iol.As a result the following fields have been updated: section b3: date of event: (b)(6) 2019.Section d10: device available for evaluation: yes.Section d10: returned to manufacturer on: 6/10/2020.Section h3: device returned to manufacturer: yes.Device evaluation: the complaint lens was received in its original lens case.Additionally, the original folding carton, patient id card, implant notification card, patient stickers, dfu, and an opened inner pouch were received.Visual inspection under magnification revealed what appeared to be dried blood and viscoelastic residue on the optic body and haptics, and that the lens was received cut (but not separated) and a detached haptic (not received), which is consistent with a lens that was handled for removal and replacement.Based on the returned condition of the lens, no further product evaluation could be performed.The complaint issue could not be confirmed, and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaints have been received for this production order.Conclusion: as a result of the investigation, 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 nr-0148919 and capa-010215.

• Brand Name: TECNIS SYMFONY
• 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: 10140326
• Report Number: 9614546-2020-00219
• Device Sequence Number: 2094692
• Product Code: POE
• UDI-Device Identifier: 05050474579217
• UDI-Public: (01)05050474579217(17)220127
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• 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): 10/30/2020
• 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: 01/27/2022
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/15/2020
• Supplement Date Received by Manufacturer: 06/10/2020; 10/25/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 07/07/2020; 10/30/2020
• 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: 62 YR
• Date Report Sent to FDA: 01/01/2005