MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS ITEC PRELOADED 1-PIECE IOL; MONOFOCAL IOLS

Model Number PCB00

Device Problem Unintended Movement (3026)

Patient Problems Capsular Bag Tear (2639); Vitrectomy (2643); No Code Available (3191)

Event Date 11/04/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).It was indicated that the device was discarded therefore a failure analysis of the complaint device cannot be completed.A review of the device/lot history record 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 Description

It was reported that the intraocular lens (iol) was explanted from the patients left eye due to the dislocation of the iol within the capsular bag with a capsule radial tear.The patient had a pars plana vitrectomy and sutures were used in the posterior chamber.The explanted iol was replaced with a non-johnson and johnson iol.The patient outcome was excellent.The explanted iol is not being returned because it was discarded.No additional information was provided.

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 (b)(4).

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9584786
• MDR Text Key: 175236588
• Report Number: 2648035-2020-00051
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558267
• UDI-Public: (01)05050474558267(17)220821
• 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
• Report Date: 01/01/2005,11/04/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2022
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000200
• 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: 12/19/2019
• Initial Date FDA Received: 01/14/2020
• Supplement Dates Manufacturer Received: 10/25/2020
• Supplement Dates FDA Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR