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

Model Number	ZXT300
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227); No Code Available (3191)
Date of Event	10/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: if explanted; give date: not applicable as the iol remains implanted in the patient's ocular dexter (right eye).(b)(4).Device evaluation: product testing could not be performed because the product was not returned as the lens remains implanted in the patient¿s ocular dexter (right 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 similar 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
It was reported the intraocular lens (iol) was implanted in the patient's ocular dexter (right eye) on (b)(6) 2019 and lens was misaligned.At implant, od iol axis placement was 004.At six (06) months, it was report od iol axis was 15.No secondary surgical intervention is planned at this time.At one (01) year study visit clinical study visual symptom questionnaire indicates the patient being extremely bothered by halos and will not drive at night, extremely bothered by starbursts, moderately bothered by multiple or double vision, very bothered by sensitivity to light, extremely bothered by glare related to scattered light, very bothered by occlusions, extremely bothered by poor low light vision.Visual symptom questionnaire also indicates patient reported this is wrong prescription lens.One (01) year visual acuity (va) was reported as: od uncorrected distance visual acuity (ucdva) 20/25 and od best corrected distance visual acuity (bcdva) 20/25.Preop va was reported as: od ucdva 20/70 and od bcdva 20/40.The subject has completed the study.No additional information was provided.This report captures the iol in the patient's ocular dexter (right eye).A separate report will be filed for the patient's ocular sinister (left eye).
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.

• 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: 10182785
• Report Number: 9614546-2020-00227
• Device Sequence Number: 3017006
• Product Code: POE
• UDI-Device Identifier: 05050474606357
• UDI-Public: (01)05050474606357(17)211119
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2020
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/19/2021
• Device Model Number: ZXT300
• Device Catalogue Number: ZXT300U185
• 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: 10/03/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 11/13/2020
• 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: Other
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005