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

Model Number PCB00

Device Problems Positioning Failure (1158); Physical Resistance/Sticking (4012)

Patient Problem No Code Available (3191)

Event Date 01/21/2019

Event Type  Injury  

Manufacturer Narrative

If implanted; give date: n/a (not applicable).The intraocular lens was removed and replaced during the same procedure.If explanted; give date: n/a (not applicable).The intraocular lens was removed and replaced during the same procedure.(b)(6).(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the trailing haptic of the pcb00 monofocal iol (intraocular lens) was stuck in the injector during implantation.Reportedly, the iol had to be removed from the patient's operative eye.The incision was enlarged and sutures were required.Another lens (model and diopter unknown) was implanted as a replacement.As a results there was a 30-minute delay in the procedure.The account commented that the post-op recovery would be delayed due the large wound with sutures plus more hospital visits.No additional information was provided.

Manufacturer Narrative

Device available for evaluation; returned to manufacturer on 3/18/2019.Device evaluation: preloaded device was observed under microscope and the plunger was observed advanced but not locked not until the hatch mark as per dfu (direction for use).The lens was observed stuck at the beginning of the cartridge.Scarce amount of viscoelastic was observed only in the cartridge tube.The haptics were not observed folded since the lens was observed at the beginning of the loading zone.The device was opened and no defects were observed in the upper body, lower body neither in the pushrod.The lens was removed and no defects were observed in the optic zone neither in the haptics.The complaint was not verified since the lens preparation was not completed.A product quality deficiency was not identified.The reported complaint was not confirmed.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 similar complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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, 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 (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: 8381176
• MDR Text Key: 137504553
• Report Number: 2648035-2019-00257
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558243
• UDI-Public: (01)05050474558243(17)210707
• 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,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: 03/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• 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