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 Problems Capsular Bag Tear (2639); Vitrectomy (2643)

Event Date 01/17/2020

Event Type  Injury  

Manufacturer Narrative

Additional information: gender/sex: unknown, information not provided implant date: explant date: not applicable as lens was removed/replaced in the initial surgery.Device evaluation: the product was returned to the manufacturing site for evaluation.The plunger and pushrod were observed in the advanced position.Residues of lubricant material was observed on cartridge.No damaged was observed to the cartridge.The lens returned outside of the preloaded device.No damaged was also observed to the lens.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 could not be verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaints for this production order number have been received.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.

Event Description

Customer reported that after insertion of an intraocular lens (iol) into the patient's right eye their capsule broke.The doctor removed the iol from the eye and performed a vitrectomy.The procedure was completed with a non-johnson & johnson lens.Through follow-up the customer explained that they are not aware of anything being wrong with the j&j lens.Additionally, the patient is doing well.No further information is available.

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 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: 10242508
• MDR Text Key: 197936604
• Report Number: 2648035-2020-00477
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558281
• UDI-Public: (01)05050474558281(17)221105
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,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: 11/05/2022
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• 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: 06/09/2020
• Initial Date FDA Received: 07/07/2020
• Supplement Dates Manufacturer Received: 10/25/2020
• Supplement Dates FDA Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR