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

Model Number PCB00V

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.Date of event: unknown, not provided.If implanted, if explanted, give date: not applicable, the lens was not implanted, procedure completed with the back-up lens.(b)(6).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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the cartridge tip of the tecnis optiblue intraocular lens (iol) model pcb00v was found to be warped during setting.It was indicated that the device had not been touched by anyone at the hospital and that it was not an operational error.The procedure was completed successfully with the back up lens and there was no patient injury reported.No further information provided.

Manufacturer Narrative

Device available for evaluation; returned to manufacturer on 9/6/2019.Device evaluation: the complaint unit was received in a plastic bag.The plunger was in a partially advanced position and lock.The cartridge was correctly engaged to the device.No assembly error and/or defect related to manufacturing process were observed.Visual inspection at microscope magnification was performed.Lubricant material residue was not observed in the device.The lens was not returned, and the cartridge tip was deformed.The reported issue was verified; however, due to the condition in which the sample was returned, it was not possible to determine that the reported issue was related to the manufacturing process.Based on the analysis, a product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.There was no discrepancy and/or deviation found during the mrr (manufacturing record review).A search on complaints revealed that no additional complaint was received for this production order.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

Additional information: additional information received confirmed that the cartridge tip damage issue was noticed when the customer opened the product.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 (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: 8963323
• MDR Text Key: 156751047
• Report Number: 2648035-2019-00961
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474561748
• UDI-Public: (01)05050474561748(17)211107
• 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,Followup,Followup
• Report Date: 01/01/2005,11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2021
• Device Model Number: PCB00V
• Device Catalogue Number: PCB00V0190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• 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