MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS CL; MONOFOCAL IOLS

Model Number	Z9002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Visual Disturbances (2140); Dizziness (2194)
Date of Event	10/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable, as the lens remains implanted.(b)(4).Device evaluation: the product was not returned to the manufacturing site as the lens remains implanted; therefore, the complaint issue reported was not verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the product.Historical data analysis: a search of complaints revealed no additional complaint was received from this production order.Conclusion: as a result of the investigation there is no indication of a quality product 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
The patient reported that he has been feeling dizzy after implant of an intraocular lens (iol) in the right eye.The patient also reported seeing floaters and after wearing eye glasses he complains of headaches.The patient indicated that he cannot read for more than 20-30 minutes at a time because of the headaches, therefore, he has a difficult time focusing.His vision at night is not as clear, so he is not comfortable driving at night.The patient had a prk (photorefractive keratectomy) performed on (b)(6) 2019, and is still in the healing process.At this time, the lens remains implanted.No additional information was provided to johnson & johnson surgical vision.Patient had bilateral lens implants.This report represent the lens implanted in patient's right 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 nr-0148919 and capa-010215.

• Brand Name: TECNIS CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8620689
• Report Number: 2648035-2019-00579
• Device Sequence Number: 2494962
• Product Code: HQL
• UDI-Device Identifier: 05050474530676
• UDI-Public: (01)05050474530676(17)220713
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2020
• 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: 07/13/2022
• Device Model Number: Z9002
• Device Catalogue Number: Z900200190
• 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: 04/18/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 11/12/2020
• 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: 58 YR
• Date Report Sent to FDA: 01/01/2005