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

Model Number PCB00

Device Problems Break (1069); Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

If implanted; give date: does not apply - lens was not implanted.If explanted; give date: does not apply - lens was not implanted and therefore not explanted.(b)(6).Device evaluation: visual inspection using magnification was performed to the returned sample: the plunger and pushrod was observed in advanced position.Residues of lubricating material and material looks like body fluids were observed on cartridge.The cartridge tip was observed damaged and crack.The lens was also observed damaged and stuck at the cartridge tip section.No damaged was observed to the preloaded device.Based on the sample evaluation, there is no evidence to suggest that the complaint unit has been affected by the manufacturing process.The condition in which the sample returned is consistent with a product that was handled and prepared for a surgical process.The complaint issue reported was verified.Based on the analyzed of the returned, there is no indication of product quality deficiency.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no similar complaint for this production order number has been received.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 has been reported issues with a pcb00.Cartridge split on the front, no further information provided.No patient involvement reported.

• 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
• Manufacturer (Section G): JOHNSON & JOHNSON SURGICAL VISION, INC.; road 402 north, km 4.2; anasco industrial park; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478200
• MDR Report Key: 11386479
• MDR Text Key: 234626010
• Report Number: 2648035-2021-00033
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558335
• UDI-Public: (01)05050474558335(17)230501
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Date Manufacturer Received: 02/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1