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

Model Number PCB00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vitrectomy (2643)

Event Date 06/10/2020

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown/not provided.Sex/gender: unknown/not provided.If implanted, give date: not applicable, as the lens was not implanted.If explanted, give date: not applicable, as the lens was not implanted; therefore, it was not explanted.Contact name and email unknown, not provided.Attempts have been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that an intraocular lens (iol) was partially inserted and cut out and removed as the patient needed a vitrectomy.No additional information was provided.

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-0148919 and capa-010215.

Manufacturer Narrative

Additional information: section d10: device available for evaluation? yes.Returned to manufacturer on: 7/29/2020.Section h3: device returned to manufacturer ¿ yes.Device evaluation: the sample was received in the packaging box.The pcb00 device was observed under microscope; the plunger was observed in advanced position to the first black line but not locked.Viscoelastic residues were not observed in the device.Per directions for use (dfu) z311134p, rev.A, the tecnis® 1-piece iol with the tecnis itec preloaded delivery system, the use of viscoelastic is required when using the tecnis itec preloaded delivery system.For optimal performance, use the amo healon® family of viscoelastics.The use of balanced salt solution alone is not recommended.Also dfu states to completely fill the viewing window with ovd.The lens was observed stuck in the cartridge tube.The leading haptic was observed unfolded inside of the tube.The pushrod was observed adhered to the lens.The lens delivery could not be completed since the lens was too hard to be removed.No complaint against the device was mentioned in the initial report however the lead haptic not folded condition was observed.This condition could be related to the handling process due to the lack of viscoelastic observed in the viewing window that do not let the lens to fold correctly inside the device during device preparation.A product quality deficiency was not identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that one other complaint has been received for this production order number, however, is not related to this complaint.Conclusion: as a result of the investigation 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 & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10368862
• MDR Text Key: 201831949
• Report Number: 2648035-2020-00581
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474558328
• UDI-Public: (01)05050474558328(17)230109
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• 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
• Patient Outcome(s): Required Intervention