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	Visual Disturbances (2140); Halo (2227); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: exact date of event is unknown, best estimate is between (b)(6) 2019.Explant date: if explanted; give date: not applicable as the iol remains implanted in the patient's left eye.Device evaluation: product testing could not be performed because the product was not returned as it remains implanted in the patient¿s left eye.A product quality deficiency could not be confirmed.The reported issue was not verified.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: a search revealed that no other complaints for this production order number have been received.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
On (b)(6) 2020, a letter was received from a female patient who underwent bilateral zxr00 intraocular lens implants.Per the patient¿s letter, cataract surgery was performed on the ocular sinister (left eye) on (b)(6) 2019, followed by cataract surgery on (b)(6) 2019, on the ocular dexter (right eye), (however per patient implant cards, left eye was implanted on (b)(6) 2019 and the right eye on (b)(6) 2019).The patient noted her understanding was that post procedure she would not need glasses and her vision would be greatly enhanced.She stated she never had a distance vision problem.Her ophthalmologist advised her there is a calming period, however, after six months the implants have not improved her vision at all, and she had to purchase more reading glasses.She cannot drive at night because of halos and spider web effects around car lights, street and highway lighting.When she attended baseball games, sight and sound performances, she would have to relocate due to bright lighting.The patient was examined by an optometrist (od) who prescribed glasses and advised her it would not be a good idea to have the lenses removed.She did not fill the prescription for glasses.The patient went back to her ophthalmologist who performed a yttrium-aluminum garnet (yag) procedure on the left eye on (b)(6) 2019 and then on the right eye (b)(6) 2019.The procedure did remove a film that was on the left eye.In a follow-up appointment on (b)(6) 2019, the patient explained to the implanting ophthalmologist there was no improvement with night vision, halos and lighting were awful.The implanting surgeon stated the lens placement was fine, and that he would remove one lens and replace it with a regular cataract surgery lens, then replace the other lens.However, a second physician advised her to not have the lens removed, but also said the lens looked in place.The patient further reported she experiences vertigo from time to time, and this vision issue has aggravated the problem, requiring her to take meclizine more frequently.She reports her life has been greatly interrupted and has caused anguish and unnecessary worry.This report captures the event for the left eye.A separate report is being submitted for the right eye (od).No additional information was provided to johnson & johnson surgical vision.
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: 9649772
• Report Number: 2648035-2020-00098
• Device Sequence Number: 13541524
• Product Code: POE
• UDI-Device Identifier: 05050474579088
• UDI-Public: (01)05050474579088(17)231207
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 12/07/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0195
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 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
• Date Report Sent to FDA: 01/01/2005