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

Model Number PCB00V

Device Problem Premature Activation (1484)

Patient Problems Edema (1820); Capsular Bag Tear (2639); Vitrectomy (2643); No Code Available (3191)

Event Date 11/25/2019

Event Type  Injury  

Manufacturer Narrative

If implanted; give date: lens was not implanted.If explanted; give date: lens was not implanted, therefore not explanted.Phone: (b)(6).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.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.Other text : placeholder.

Event Description

It was reported that the iol went out the cartridge too fast.It seemed that the mechanism was dysfunctional.This caused a rupture of the capsular bag requiring intervention.The lens was removed from the eye.The patient's visual acuity pre-operative: 3/10, visual acuity post-operative: hand motion.No additional information was provided.

Manufacturer Narrative

Additional information: through follow-up we learned that during the implantation of the iol pcb00v +25.0d in the capsular bag, the iol (intraocular lens) went out the injector suddenly and too fast and hit the nasal part of the eye.After that the surgeon noticed a rupture of the posterior bag and the anterior nasal.The iol was removed and a vitrectomy performed.No lens was implanted.One day post-op a corneal edema was noticed.No additional information was provided.As a result of the additional information provided, the following patient codes have been added: (b)(4) aphakic.Device evaluation: product testing was not performed since the product was not returned for evaluation.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing record evaluation: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification. a search revealed that no additional complaints for this order number have 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.

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 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: 9513668
• MDR Text Key: 176630383
• Report Number: 2648035-2019-01372
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474561861
• UDI-Public: (01)05050474561861(17)220813
• 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,Followup
• Report Date: 01/01/2005,11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2022
• Device Model Number: PCB00V
• Device Catalogue Number: PCB00V0250
• 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
• Patient Age: 55 YR