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

Model Number PCB00

Device Problem Delivery System Failure (2905)

Patient Problem No Code Available (3191)

Event Date 03/13/2018

Event Type  malfunction  

Manufacturer Narrative

The intraocular lens was not implanted.(b)(4).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that an intraocular lens (iol) was stuck in the cartridge.The customer reported that there was patient contact with the product in the right eye.However, the iol was not partially delivered into the eye.The procedure was completed successfully with a back-up lens.There was incision enlargement.The replacement lens was pcb00 serial number: (b)(4).There were no issues with the patient when discharged.There was no vitrectomy and no sutures were required.No additional information was provided to johnson and johnson surgical vision, inc.

Manufacturer Narrative

Device available for evaluation? yes.Returned to manufacturer on: 04/11/2018.Device returned to manufacturer? yes.Device evaluation:the device was returned to the manufacturer.Visual inspection was performed.The plunger was in advanced and locked position, as the preparation of the device requires.The lens was received out of the device, with part of the lens near the haptic broken.This could be caused by the pushrod.There was a trace amount of viscoelastic observed inside the cartridge.No assembly or damages were observed in the device.The complaint reported was not confirmed and no product deficiency was identified.Manufacturing record review:manufacturing record review of the production order and related document revealed that the product was manufactured and released according to specification.There was no discrepancy found during the review.A search revealed that no other complaint was received from this production order.Labeling review:the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion:based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; santa ana CA
• Manufacturer (Section G): JOHNSON AND JOHNSON SURGICAL VISION, INC.; road 402 north, km 4.2; anasco industrial park, pob 14; anasco PR 00610
• Manufacturer Contact: pamela mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 7431304
• MDR Text Key: 105506484
• Report Number: 2648035-2018-00517
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558274
• UDI-Public: (01)05050474558274(17)210102
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/02/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2018
• 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
• Patient Outcome(s): Required Intervention