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

Model Number PCB00V

Device Problems Break (1069); Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).This report is being filed on an international device; tecnis optiblue 1-piece iol, model pcb00v that has a similar device, tecnis 1-piece iol model pcb00 which is distributed in the unites states under pma p980040.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that there was a little resistance when the plunger lock was released.Lens model, pcb00v monofocal iol (intraocular lens) was confirmed damaged after being inserted in patient's eye.As a result, the lens was removed by cutting with a lens cutter.Reportedly, there was no patient injury.No additional information provided.

Manufacturer Narrative

Device available for evaluation?: yes, returned to manufacturer on: 02/11/2019, device returned to manufacturer?: yes.Device evaluation: the intraocular lens was received at the manufacturing site for investigation.The pcb00 insertion device was received inside the original box on 02/11/2019.The plunger was observed in advanced position.The pcb00 device was observed under microscope and scarce amount of viscoelastic was observed at the cartridge.The directions for use (dfu) states to completely fill the viewing window of the pcb00 with ovd (viscosurgical device).There was no damage or errors observed on the assembly.The lens was received cut.The condition observed is consistent with a lens that has been removed/explanted.The reported issue was not verified.Manufacturing record review: a review of the manufacturing records was performed.The devices were manufactured within specifications.The units were released according to specification.Historical analysis: a search on complaints revealed that no other complaint has been received for this production order number.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions, precautions, along with warnings for the proper use and handling of the product.Based on the results of the investigation, a product quality deficiency nor a product malfunction could be 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 (b)(4) and capa-010215.

• Brand Name: TECNIS OPTIBLUE 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: 8340326
• MDR Text Key: 136286028
• Report Number: 2648035-2019-00192
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474561847
• UDI-Public: (01)05050474561847(17)200617
• Combination Product (y/n): Y
• 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: 02/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2020
• Device Model Number: PCB00V
• Device Catalogue Number: PCB00V0240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• 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