MAUDE Adverse Event Report: JOHNSON AND JOHNSON SURGICAL VISION, INC. TECNIS 1-PIECE; MONOFOCAL IOLS

Model Number ZCB00

Device Problem Difficult to Insert (1316)

Patient Problem Vitrectomy (2643)

Event Date 06/27/2018

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.If explanted; give date: no indication of lens explant.It was indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device 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 and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the doctor had issues when implanting the lens.There was no patient injury; however, a vitrectomy was performed.No additional information was provided to johnson and johnson surgical vision, inc.

Manufacturer Narrative

Based on follow-up received on 8/17/2018, the following section has been updated accordingly: additional information: lens was opened, but not used.The doctor changed to a different lens size instead.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

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 1-PIECE
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7714839
• MDR Text Key: 114860916
• Report Number: 3011852734-2018-00138
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474531697
• UDI-Public: (01)05050474531697(17)210601
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,10/30/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2021
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 06/29/2018
• Initial Date FDA Received: 07/24/2018
• Supplement Dates Manufacturer Received: 08/17/2018; 10/25/2020
• Supplement Dates FDA Received: 09/10/2018; 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention