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

Model Number PCB00V

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).This report is being filed on an international product, intraocular lens (iol) model number pcb00v that has a similar product distributed in the united states, iol model no.Pcb00, which falls under pma (b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the cartridge tip of a preloaded delivery system, model pcb00v, was noticed to be bent during implantation of the intraocular lens.Reportedly, the procedure was completed successfully with the backup lens.There was no patient injury.No addition information is provided.

Manufacturer Narrative

Device available for evaluation, returned to manufacturer on 04/10/2018.Device evaluation: the pcb00v product was returned in its original package.Visual inspection at 10x microscope magnification was performed.The plunger and pushrod were observed partially advanced in the preloaded insertion system.Lack of lubricant material was observed on the cartridge.Slight distortion was also observed at the cartridge tip section.The lens was observed stuck in the cartridge.One of the haptics was observed exposed at the cartridge tip.No assembly errors and/or defects were observed in the preloaded device related to the manufacturing process.However, the condition of the product returned is consistent with a unit that has been previously handled and prepared for surgical use.The complaint issue was verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no additional investigation requests for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The dfu provide the customer with proper usage instructions and guidelines.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.

• Brand Name: TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• Manufacturer (Section G): JOHNSON & 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: 7398909
• MDR Text Key: 104431103
• Report Number: 2648035-2018-00462
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474561786
• UDI-Public: (01)05050474561786(17)200405
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/05/2020
• Device Model Number: PCB00V
• Device Catalogue Number: PCB00V0210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2017
• 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