MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. HEALON ENDOCOAT; OVDS

Model Number VT585U

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2020

Event Type  malfunction  

Manufacturer Narrative

Sex/gender: unknown/ not provided.If implanted; give date: not applicable as the healon endocoat is not an implantable device.If explanted; give date: not applicable as the healon endocoat is not an implantable device.Initial reporter's first name: unknown, not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the vial of the healon endocoat, model vt585u broke upon injecting the product into the patient's eye.That the surgeon placed the needle in the patient's eye to inject the endocoat and when advancing the plunger the vial broke.It was noted that the customer did not feel a lot of resistance and did not have to apply extra pressure that would have caused the vial to break.It was confirmed that the glass did not fall into the patient's eye, that the procedure was completed successfully and there was no patient injury reported.It was indicated that the device is available for return.No additional information was provided.

Manufacturer Narrative

The product testing could not be performed as the product was not returned for evaluation.Only a photo of the complaint unit was provided for evaluation.This photo confirms the complaint indication.Batch record review determined that there were no processing deviations or comments that would contribute to the reported complaint indication.The overall reject rate was 1%, which is within the allowable limit of 5%.There were no deviations or related comments in the receiving inspection reports.The final disposition of the raw materials was to accept.A review of the complaint database indicates that there have not been any complaints regarding damaged components for the healon product line in the last year.No trend has been identified.No specific manufacturing root cause could be identified based on the review of the batch record and receiving inspection documents.The investigation shows that the raw material syringes used to manufacture the complaint lot were acceptable.Syringe units are subjected to two 100% inspections, visual inspection defect criteria, prior to cartooning and inspections were found to be acceptable.Root cause related to the manufacturing process has been identified.The risks associated with damaged or broken components are evaluated in the current risk assessments.No new risks were identified.This investigation shows the lot meets product specifications.Batch record review indicates the inspection process functioned as intended during routine inspection.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 (b)(4).

• Brand Name: HEALON ENDOCOAT
• Type of Device: OVDS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9718759
• MDR Text Key: 186750365
• Report Number: 3004750704-2020-00010
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Public: (01)(17)210430(10)028106
• Combination Product (y/n): Y
• PMA/PMN Number: P110007
• 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: 01/01/2005,11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: VT585U
• Device Catalogue Number: VT585U
• Device Lot Number: 028106
• Was Device Available for Evaluation?: No
• 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: 01/21/2020
• Initial Date FDA Received: 02/17/2020
• Supplement Dates Manufacturer Received: 02/19/2020; 10/25/2020
• Supplement Dates FDA Received: 03/17/2020; 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR