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

Model Number	Z9002
Medical Device Problem Codes	Pitted (1460); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	12/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lens remains implanted.The device is not returning for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record, labeling, complaint trending, and risk documentation 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, 21.0 diopter intraocular lens (iol) has pitting on the back-surface post implantation.Yttrium aluminum garnet (yag) procedure was done thinking it was posterior capsule, but it was not.Per information on the received complaint form, the lens remains implanted.Problem observed on (b)(6) 2018.Lens has appearance of a secondary cataract, but after capsulotomy was performed, debris/pitting was still present, od (right eye).Patient noted to have haziness of vision for some time.Appearance of posterior capsule opacity, yet haziness on posterior aspect of lens remained in spite of opening posterior capsule.No secondary surgical procedure required.No plan to explant.Visual acuity (va) pre-op, 20/30; va post-op, 20/30.No additional information was provided.
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-(b)(4) and capa-010215.

• Brand Name: TECNIS CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; 1700 east st. andrew place; santa ana CA 92705
• MDR Report Key: 8251612
• Report Number: 2648035-2019-00074
• Device Sequence Number: 11293943
• Product Code: HQL
• UDI-Device Identifier: 05050474530713
• UDI-Public: (01)05050474530713(17)141217
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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): 11/06/2020
• 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: 12/17/2014
• Device Model Number: Z9002
• Device Catalogue Number: Z900200210
• 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: 12/18/2018
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 11/06/2020
• 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: 62 YR
• Date Report Sent to FDA: 01/01/2005