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

Model Number HEALON 0.85

Device Problem Contamination (1120)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.Date of event: unknown, not provided.Lot number: unknown, information not provided.Unique device identifier (udi #): unknown, as lot number was not provided.Expiration date: unknown, as lot number was not provided.If implanted, give date: not applicable as this is not an implantable device.  if explanted, give date: not applicable as this is not an implantable device.  facility name: unknown, not provided.(b)(6).Device manufacture date: unknown as lot number was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that something like fiber came out in the patient eye when pushed to the end.The customer experienced it twice.No patient injury reported.No further information provided.This report captures the first of two events.

Manufacturer Narrative

Device evaluation: the complaint sample was not returned to the manufacturing site; therefore, product testing could not be performed, and the customer's reported complaint could not be verified.Manufacturing record evaluation: manufacturing record review cannot be performed since the lot number is unknown.A search of complaints related to lot number cannot be performed since the lot number is unknown.Conclusion: no sample was returned and lot number is unknown an investigation could not be performed, and no malfunction is confirmed.No escalation is required.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
• Type of Device: OVDS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9096403
• MDR Text Key: 176417753
• Report Number: 3004750704-2019-00032
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): Y
• PMA/PMN Number: P810031
• 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: 01/01/2005,11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HEALON 0.85
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• 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
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1