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); Difficult to Insert (1316)

Patient Problem No Code Available (3191)

Event Date 05/16/2018

Event Type  Injury  

Manufacturer Narrative

As lens was removed/replaced in the initial surgery.(b)(6).(b)(4).Device evaluation: product testing could not be performed as the product was not returned., was discarded.The reported complaint cannot be confirmed.A photographic of the lens was provided; however, due to the photo resolution the 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.A search on complaints revealed that no other complaints were received for this production order number.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.

Event Description

It was reported that preloaded intraocular lens (model pcb00, +22.0 diopter) had issues after perfectly pushing the 2 steps of the delivery system and following the directions for use.It was reported that the trailing haptic was wrapped around the plunger.The lens was partially delivered.Nothing was helping the surgeon, hence the surgeon cut off the last haptic with the knife and the lens was removed and replaced with another pcb00 lens.There was wound enlargement and patient injury reported.A 15 minute delay in the procedure was reported and the surgeon was not happy with the quality of the lens.Everything was normal again with patient¿s eye and there was no damage to the eye.No further information provided.

Manufacturer Narrative

Device available for evaluation? yes.Returned to manufacturer on: 08/24/2018.Device returned to manufacturer? yes.Device evaluation: the preloaded delivery system was returned at the manufacturing site for evaluation.The plunger was observed in completely advanced position and locked.Visual inspection under the microscope showed scarce amount of lubricant residue inside the device.Only a piece of haptic was observed stuck in the cartridge tip.The intraocular lens (iol) was received out of the device.It lens had part of the optic edge broken and the trailing haptic detached.This condition could be caused by the extra force applied to deliver the lens due to the scarce amount of viscoelastic used.The dfu (directions for use) states to completely fill the viewing window with ovd (ophthalmic viscosurgical device).The customer's reported complaint was verified however it could be related to the handling process.No product quality deficiency was identified.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 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: 7729249
• MDR Text Key: 115348721
• Report Number: 2648035-2018-01054
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558304
• UDI-Public: (01)05050474558304(17)210321
• 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: 01/01/2005,10/30/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2018
• 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: 05/18/2018
• Initial Date FDA Received: 07/27/2018
• Supplement Dates Manufacturer Received: 09/21/2018; 10/25/2020
• Supplement Dates FDA Received: 10/18/2018; 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention