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

Model Number PCB00V

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Edema (1820)

Event Type  Injury  

Manufacturer Narrative

Serial number: unknown, information not provided.Catalog number: a complete catalog number is unknown, as serial number was not provided.Unique device identifier (udi #): unknown, as serial number was not provided.Expiration date: unknown, as serial number was not provided.If implanted, give date: unknown, information not provided.If explanted, give date: unknown, information not provided.(b)(6).Device manufacture date: unknown as serial number was not provided.This report is being filed on an international device; tecnis optiblue 1-piece iol, model pcb00v that has a similar device, tecnis 1-piece iol model pcb00 which is distributed in the unites states under pma p980040.Device evaluation: the complaint is not associated any specific pcb00v unit, therefore, there is no product expected to be returned for evaluation.If the product is received after initial closure, the ir and cf may be re-opened to complete the investigation as stated (b)(4).Manufacturing records review: the manufacturing records for the product were not reviewed.A search on complaints related to a production order could not be performed since the product identifiers are not available.Labeling review: limited information was received, the issue reported was not associated to any particular content on the dfu.However, the labeling review was completed and revealed that the directions for use (dfu) tecnis itec preload pcb00, provide the customer with proper usage instructions and guidelines.No labeling changes are required.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that macular edema were observed.No other information 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 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: 8689523
• MDR Text Key: 147720962
• Report Number: 2648035-2019-00631
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PCB00V
• Device Catalogue Number: PCB00V
• 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): Other