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

Model Number PCB00

Device Problems Crack (1135); Deformation Due to Compressive Stress (2889)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/30/2019

Event Type  malfunction  

Manufacturer Narrative

If implanted; give date: n/a (not applicable).The intraocular lens was not implanted.If explanted; give date: n/a (not applicable).The intraocular lens was not implanted; therefore, it was not explanted.(b)(6).Device evaluation: the product was returned to the manufacturing site 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.The cartridge tip was observed deformed and the tube was observed with a crack.The lens was also observed stuck in cartridge.The condition in which the sample returned is consistent with a product that was handled and prepared for a surgical process.The reported complaint issue reported was verified; however, based on the analyzed of the returned device, there is no indication of product quality deficiency.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.There was no discrepancy found during the mrr (manufacturing record review).The product was manufactured and released according to specifications.A search revealed that no additional complaint was received for this production order number.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 has been submitted.

Event Description

It was reported that the intraocular lens (iol), model pcb00 herniated to the side of the introducer.As the surgeon started to wind the introducer the lens was coming out of the side of the introducer, not coming out of the tip.It was indicated that there must have been a crack in the introducer which the lens came out from the side of the cartridge.The issue was observed when inserting the lens and when the cartridge tip contacted the eye.The lens was not implanted and it did not come into contact with the patient patient¿s eye.There was a two (2) minutes delay during the procedure.There were no surgical interventions such as incision enlargement, vitrectomy or sutures required.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 (b)(4) and capa-010215.

• 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: 9258760
• MDR Text Key: 165231303
• Report Number: 2648035-2019-01161
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474619951
• UDI-Public: (01)05050474619951(17)220125
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• 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: 01/01/2005,11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2022
• Device Model Number: PCB00
• Device Catalogue Number: PCB000A225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• 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
• Patient Age: 65 YR