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

Model Number PCB00V

Device Problems Break (1069); Difficult to Insert (1316); Separation Problem (4043)

Patient Problem No Code Available (3191)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

If implanted; if explanted, give date: the intraocular lens was inserted and removed during the same procedure (b)(6).Pma/510(k) : this report is being filed on an international device; tecnis optiblue itec preloaded 1-piece iol, model pcb00v that has a similar device, tecnis 1-piece iol model pcb00 which is distributed in the united states under pma p980040.(b)(4).Device evaluation: product was not available; therefore, a product evaluation was not possible.The reported issue could not be verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed no additional investigation request (ir) for this production order number has been received.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that during a cataract surgery, surgeon had an issue with a monofocal lens, model tecnis optiblue.During the insertion of the intraocular lens, the surgeon had difficulty to deliver it through the 2.4 incision with the cartridge.The lens was partially already out of the injector.He decided to continue the injection, the lens opened normally but the haptic was detached from the optical body.Lens was removed and replaced during the same visit.However during the procedure, the incision have been enlarged in order to remove the intraocular lens from the eye and extra sutures were necessary.All the information available were 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 (b)(4) and capa-010215.

• Brand Name: TECNIS OPTIBLUE 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: 9462392
• MDR Text Key: 170731900
• Report Number: 2648035-2019-01317
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474561786
• UDI-Public: (01)05050474561786(17)220825
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• 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

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2022
• Device Model Number: PCB00V
• Device Catalogue Number: PCB00V0210
• 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
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention