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

Model Number	ZXT300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227); No Code Available (3191)
Date of Event	12/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable, as lens remains implanted.(b)(4).Device evaluation: product evaluation was not performed because the product is still implanted in the patient¿s eye.The complaint issue reported could not be verified and no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search of complaints related to this production order (po) was performed and one file was found as part of this po.However, the complaint issue is not related to this complaint investigation.No further actions or escalations are required.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.
Event or Problem Description
It was reported that a clinical study patient had bilateral tecnis toric symfony intraocular lenses (iols) implanted.The subject at a 1 month visit reported extremely that she was bothered by starbursts while driving and moderately bothered by glare related to scattered light while driving.In the non-directed ocular visual symptoms the subject complained severe starbursts- both eyes (ou).The monocular uncorrected distance visual acuity (ucdva) ¿ right eye (od) 20/20; left eye (os) 20/20.Monocular best corrected distance visual acuity (bcdva) ¿ od 20/15; os 20/15.However, for the 6 month visit, bcdva: 20/20 od; 20/15 os.Medical findings significant for posterior capsular opacification (pco) ou.But there was no yttrium aluminum garnet (yag) capsulotomy planned.Also, the subject reported a complaint of ocular visual symptoms as extremely bothered by starbursts ¿ ¿drive at night¿; extremely bothered by glare related to scattered light- ¿drive at night¿.In the non-directed visual symptoms complaints in the left eye include blurred vision/difficulty with vision- near; mild halos; severe starbursts and difficulty with vision in low light.The subject did state the symptoms significantly impacted daily activities.Still no intervention planned.This mdr report pertains to the left eye (os).A separate report will be submitted for the right eye (od).
Additional Manufacturer Narrative
Additional information: section h6: patient code 3191: double vision.Section h6: patient code 3191: photophobia.Upon further follow-up it was learned that the patient is this time moderately bothered by halos- ¿blue halo around moon and stars¿; very bothered by multiple or double vision- ¿seeing far away¿; very bothered by sensitivity to light- ¿driving-reading¿.Yttrium aluminum garnet (yag) capsulotomy is planned for both eyes, but has not yet been scheduled.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.
Additional Manufacturer Narrative
Corrected data: upon further review it was noted that a correction on typo in 3rd follow-up for mfr report number 9614546-2020-00170 should be submitted.3rd follow-up indicated right eye (od) when report should actually be for left eye (os) instead.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Upon further follow-up, yttrium-aluminum garnet (yag) laser, right eye (od) was performed.The subject was seen for follow-up and stated they were doing well and were happy, visual acuity (va) was od 20/20 uncorrected.Section below updated.Section h6: patient code: 3191: yag.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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: 9924437
• Report Number: 9614546-2020-00170
• Device Sequence Number: 3296748
• Product Code: POE
• UDI-Device Identifier: 05050474606289
• UDI-Public: (01)05050474606289(17)220609
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/11/2021
• 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: 06/09/2022
• Device Model Number: ZXT300
• Device Catalogue Number: ZXT300U150
• 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: 03/09/2020
• Supplement Date Received by Manufacturer: 10/05/2020; 10/25/2020; 12/11/2020; 01/11/2021
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 11/03/2020; 11/04/2020; 01/09/2021; 01/11/2021
• 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: Other
• Patient Age: 69 YR
• Date Report Sent to FDA: 01/01/2005