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	Halo (2227); No Code Available (3191)
Date of Event	07/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: exact date not provided, only that symptoms were first noted immediately post-op, therefore date of one day post-op is provided as the best estimate date.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The customer reported bilateral lens explants of tecnis symfony intraocular lenses (iol), model zxr00 due to the female patient experiencing disabling halos and glare.Symptoms were first noted immediately post-op for both eyes.It was indicated at explant that the incision was enlarged to remove the iol and sutures were required.A replacement lens, model zcb00 24.5 diopter was used.No other surgical/medical interventions were reported.The patient's outcome was reported to be favorable, stable after the iol exchanges and there was no patient injury reported.It was indicated that the lenses are available for return.No additional information was provided.Visual acuity pre-op 20/70; 20/60, visual acuity post-op 20/20; 20/25.This mdr report pertains to the right eye (od).A separate report will be submitted for the left eye (os).
Additional Manufacturer Narrative
Device available for evaluation; returned to manufacturer on: 3/3/2020.Device evaluation: the lens was received in its replacement lens daisy wheel.Visual inspection under magnification revealed that the lens was received almost cut in half (but not separated), which is consistent with a lens that was handled during explant.Additionally, viscoelastic residue was observed on the optic body and haptics.A haptic stuck to the optic body and a detached haptic were also observed, however, how and when these defects occurred cannot be confirmed.After cleaning the lens, the haptic stuck to the optic body was no longer observed.Based on the condition of the return lens, no further product evaluation could be performed.The complaint issue could not be confirmed, and no product deficiency was identified.Manufacturing records review: the manufacturing process record was evaluated and no deviations were found during process related to the complaint issue reported.The product was manufactured and released according to specifications.A search in complaint system revealed no other complaints have been received for this production order number.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 (b)(4) and capa(b)(4).

• 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: 9635385
• Report Number: 2648035-2020-00079
• Device Sequence Number: 2922960
• Product Code: POE
• UDI-Device Identifier: 05050474579156
• UDI-Public: (01)05050474579156(17)230724
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2020
• 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: 07/24/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/02/2020
• Supplement Date Received by Manufacturer: 03/06/2020; 10/25/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 04/02/2020; 11/04/2020
• 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: 71 YR
• Date Report Sent to FDA: 01/01/2005