MAUDE Adverse Event Report: JOHNSON AND JOHNSON SURGICAL VISION, INC. TECNIS; MONOFOCAL IOLS

Model Number ZA9003

Device Problem Difficult to Insert (1316)

Patient Problem Vitrectomy (2643)

Event Date 06/27/2018

Event Type  Injury  

Manufacturer Narrative

Reportedly, the lens was not implanted; therefore not explanted.Reason for non-evaluation: it was indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record, labeling, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the doctor had issues when implanting the lens.A vitrectomy was performed.However, there was no patient injury.Further information was provided and reported the following additional details on the event.This was a complex case.The za9003 lens wasn¿t able to be implanted.Implantation was attempted with the emerald injector and emerald cartridge.There wasn¿t a problem with the lens or cartridge.No additional information was provided to johnson and johnson surgical vision, inc.

Manufacturer Narrative

(b)(6).Sex/gender: male.Based on new information received, patient's affected eye was in the left eye (os).Vitrectomy was not planned, but performed prior to lens implant.Patient's eye anatomy had a dense white cataract, small pupil size and was unable to maintain still during procedure.Per account, trypan blue was use to stain and malyugin ring was placed for better exposure.Kuglen hooks and healon gv was also used.Phaco emulsification was performed.Nucleus was removed using a lens loop.Surgeon had concern regarding posterior capsule post nuclear removal.Machine vitrectomy was then performed.The doctor attempted to place a sulcus lens, but the doctor was unsuccessful due to patient squeezing his eye and moving too many times.Patient was discharged in stable condition and awaiting lens implant, which is expected around august under general anesthesia.Device available for evaluation? yes.Returned to manufacturer on: 8/22/2018.Device returned to manufacturer? yes.Device evaluation: the returned za9003 lens was received in the lens case inside the original packaging box.The lens was observed under microscope.The complaint issue reported as delivery issue was not verified.Although the lens was observed with a haptic damaged, there is no evidence to suggest that the complaint sample has been affected by the manufacturing process.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.There was no discrepancy found during the mrr (manufacturing record review).The product was manufactured and released according to specifications.A search revealed that no other complaint has been received for this production order.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: 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 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 (b)(4) and capa-(b)(4).

• Brand Name: TECNIS
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7728913
• MDR Text Key: 115348122
• Report Number: 2648035-2018-01053
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474528970
• UDI-Public: (01)05050474528970(17)220509
• Combination Product (y/n): Y
• PMA/PMN Number: P990080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• 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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2022
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• 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: 06/29/2018
• Initial Date FDA Received: 07/27/2018
• Supplement Dates Manufacturer Received: 07/30/2018; 10/25/2020
• Supplement Dates FDA Received: 08/28/2018; 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EMERALD INJECTOR & CARTRIDGE LOT/SERIAL #''S UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR