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

Model Number	Z9002
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date 2014.Explant date: not applicable.To date the lens remains implanted.The device is not returning for evaluation as to date it remains implanted; therefore a failure analysis of the complaint device cannot be completed.A review of the device/lot history record for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a z9002 intraocular lens (iol) has opacified post implant.The opacification was first noted in 2014 but has worsened since then.A yag procedure was performed, but it was determined that the opacification was due to the iol not the bag.The opacification has continued to worsen; visual acuity is down to 20/60.Additional information received reported that the patient has experienced a loss of vision: bcva 20/25-1 (2014), bcva 20/60+1 (2019).There has been no patient injury and no intervention planned as of yet.Possible iol exchange is in discussion.The patient notes blurring with reading and driving, which significantly affects his daily activities.The iol remains implanted.No additional information was received.
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
• 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: 8900101
• Report Number: 2648035-2019-00887
• Device Sequence Number: 11314340
• Product Code: HQL
• UDI-Device Identifier: 05050474530669
• UDI-Public: (01)05050474530669(17)150316
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2020
• 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: 03/16/2015
• Device Model Number: Z9002
• Device Catalogue Number: Z900200185
• 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: 07/25/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 11/11/2020
• 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
• Date Report Sent to FDA: 01/01/2005