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

Model Number PCB00

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 11/30/2018

Event Type  Injury  

Manufacturer Narrative

The intraocular lens was removed and replaced during the same procedure.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that trailing haptic of model pcb00 tecnis monofocal iol (intraocular lens) was missing after it was implanted in patient's right eye (od).As a result, lens was removed and replaced during the same procedure.It was noted also that there was incision enlargement and there was suture required, but there was no vitrectomy performed.No additional information provided.

Manufacturer Narrative

Device available for evaluation: yes.Returned to manufacturer on: 01/18/2019 device evaluation: the product was returned to the manufacturing site for evaluation.The plunger and pushrod were observed in advanced position.Residue of viscoelastic material was observed on cartridge.No assembly error and/or defect were observed in the preloaded device related to manufacturing process.The condition in which the sample was returned is consistent with a product that was handled and prepared for a surgical process.The lens was received out of the device.The iol (preloaded) was observed without a haptic and cut in two pieces.The complaint issue of haptic detached could be confirmed.However, in the condition the sample was received, it could not be determined to be a product deficiency.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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 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.; santa ana CA 92705
• MDR Report Key: 8207286
• MDR Text Key: 131761470
• Report Number: 2648035-2018-01690
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558199
• UDI-Public: (01)05050474558199(17)211002
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• 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
• Report Date: 01/01/2005,11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 69 YR