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

Model Number TG85ML

Device Problem Contamination (1120)

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

Event Date 11/04/2020

Event Type  malfunction  

Manufacturer Narrative

If implanted; give date: n/a.Healon is not an implantable device.If explanted; give date: n/a.Healon is not an implantable device; therefore, not explanted.Phone: (b)(6).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the surgeon discovered a small foreign object coming out from the healon gv pro syringe when inserting it into the eye.He then retracted this small object with a new 1ml syringe which is being returned.No additional information was provided.

Manufacturer Narrative

Section d10 - returned to manufacturer? yes.Section d10 - date returned to manufacturer: 14th january 2021.Section h3 - device evaluated by manufacturer? yes.Device evaluation: a plastic syringe was returned and no particle was found in the remaining drops of the solution.Based on the product returned evaluation a product quality deficiency or product malfunction could not be determined.Manufacturing record evaluation: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification. a search revealed that no additional/similar (as applicable) complaints for this order number have been received.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: HEALON GV PRO
• Type of Device: OVDS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10984629
• MDR Text Key: 220720728
• Report Number: 3004750704-2020-00063
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474709522
• UDI-Public: (01)05050474709522(17)230531(10)UH31302
• Combination Product (y/n): Y
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: TG85ML
• Device Catalogue Number: 10291014
• Device Lot Number: UH31302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1