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

Model Number PCB00

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

Patient Problem Vitrectomy (2643)

Event Date 06/17/2020

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.If implanted; if explanted; give date: n/a (not applicable).The intraocular lens was not implanted.Initial reporter name: unknown/ not provided.An attempt has 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.

Event Description

It was reported that the patient had to have a vitrectomy.It was stated that there was patient contact but the lens was not inserted.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 nr-0148919 and capa-010215.

Manufacturer Narrative

Section d10.Device available for evaluation? yes; returned to manufacturer on: 08/28/2020.Section h3.Device returned to manufacturer? yes.Device evaluation: the pcb00 product was returned in its original package.Visual inspection using magnification was performed to the returned sample: the plunger and pushrod was observed in advanced position.Residues of lubricant material was observed on cartridge.No damaged was observed to the cartridge.The lens returned outside the preloaded device and cut in two pieces.The condition in which the sample returned is consistent with a product that was handled and prepared for a surgical process.Based on the information provided, there was no failure against the lens reported.There is no indication of product quality deficiency.Manufacturing records review: the manufacturing records and related documents for the production order of the device were reviewed and no discrepancies were found during the mrr (manufacturing record review).The units were manufactured and released according to specifications.A search in complaint system revealed that no additional complaint folders have been received for this product order number.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.

• 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: 10398656
• MDR Text Key: 202672722
• Report Number: 2648035-2020-00608
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558274
• UDI-Public: (01)05050474558274(17)230311
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,10/29/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• 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: 07/17/2020
• Initial Date FDA Received: 08/12/2020
• Supplement Dates Manufacturer Received: 09/03/2020; 10/25/2020
• Supplement Dates FDA Received: 09/16/2020; 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention