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

Model Number	ZXT375
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); No Code Available (3191)
Date of Event	09/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable, as lens remains implanted.(b)(4).Device evaluation: product testing could not be performed because the product was not returned as it remains implanted.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.The search revealed that no similar complaints were received for this production order number.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 in a clinical study that a zxt375 intraocular lens (iol) was implanted in a patient.The site noted an axis misalignment of 24 degrees (lens was placed at 129) and it was noted at 153 during this 1 week post-op visit on (b)(6) 2019.Follow-up confirmed the patient's visual issues were of blurred vision overall.Lens repositioning occurred the same day on (b)(6) 2019.The lens remained implanted.Vision improved, uncorrected visual acuity (ucva) 20/30, best corrected visual acuity (bcva) 20/25.No other information was provided.
Additional Manufacturer Narrative
Additional information: subject came in for their 6 month study visit.Uncorrected distance visual acuity (ucdva) right eye (od) 20/25, left eye (os) 20/20; best corrected distance visual acuity (bcdva) od 20/25, os 20/20.Subject reported the following complaints on the patient reported visual symptom questionnaire (prvsq) questionnaire: slightly bothered by poor low light vision- reading in dim light.No other information was provided.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.

• 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: 9131116
• Report Number: 9614546-2019-00926
• Device Sequence Number: 11199851
• Product Code: MFK
• UDI-Device Identifier: 05050474606739
• UDI-Public: (01)05050474606739(17)211002
• 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: health professional,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2020
• 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: 10/02/2021
• Device Model Number: ZXT375
• Device Catalogue Number: ZXT375U080
• 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: 09/05/2019
• Supplement Date Received by Manufacturer: 02/19/2020; 10/25/2020
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 03/06/2020; 11/10/2020
• 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: 30 YR
• Date Report Sent to FDA: 01/01/2005