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

Model Number PCB00

Device Problems Difficult or Delayed Positioning (1157); Positioning Failure (1158)

Patient Problem No Code Available (3191)

Event Date 07/19/2018

Event Type  Injury  

Manufacturer Narrative

If implanted, give date: not applicable, as the lens was inserted and removed.If explanted, give date: not applicable, as the lens was inserted and removed.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a pcb00 29.5 diopter lens came out of the injector too soon when inserting into the patient's right eye (od).Therefore, the lens was removed and replaced with a back up lens of the same model and diopter.There was an incision enlargement made, but no sutures were used.Reportedly, there was no patient contact.No additional information was provided.

Manufacturer Narrative

Device evaluation: the product was not returned to the manufacturing site.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing records for the product was 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

Device available for evaluation: yes.Returned to manufacturer on: 11/27/2018.Device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.A visual inspection and evaluation using magnification was performed.Viscoelastic residue was observed in the lens returned.Also, a detached haptic was observed.The plunger and pushrod were observed in advanced position.Residue of viscoelastic material was observed in the cartridge tube area.No damaged was observed to the cartridge.No assembly error and/or defect was observed in the preloaded device related to manufacturing process.The condition in which the sample returned is consistent with a product that was handled and prepared for a surgical process.Based on the evaluation, the complaint issue reported was not verified.A product deficiency was not determined.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-(b)(4) and capa-(b)(4).

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7823003
• MDR Text Key: 118437782
• Report Number: 2648035-2018-01167
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558458
• UDI-Public: (01)05050474558458(17)210420
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/01/2005,11/02/2020

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: 04/20/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• 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: 08/01/2018
• Initial Date FDA Received: 08/28/2018
• Supplement Dates Manufacturer Received: 09/21/2018; 11/29/2018; 10/25/2020
• Supplement Dates FDA Received: 09/24/2018; 12/13/2018; 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR