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

Model Number TH85ML

Device Problem Contamination (1120)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2020

Event Type  malfunction  

Manufacturer Narrative

Lot number: unknown, as information was not provided.Expiration date: unknown as product lot number was not provided.Udi #: udi # is unknown as product lot number was not provided.If implanted, give date: not applicable, as the healon pro is not an implantable device.If explanted, give date: not applicable, as the healon pro is not an implantable device.Device manufacture date: unknown, as the lot number was not provided.Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing record could not be reviewed since the lot number was not provided.Conclusion: as a result of the investigation and based on limited information available, it cannot be determined if there is a product malfunction.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a healon pro had a white particle that came out of the tip (cannula).Through follow-up, it was learned that there was patient contact.The white particle was in the eye, however, the surgeon was able to remove it from the patient's operative eye.There was no patient injury.It was confirmed the cannula was not being reused.The healon and debris is not available for return as it has been discarded.No additional information was provided.

• Brand Name: HEALON PRO
• Type of Device: OVDS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• Manufacturer (Section G): JOHNSON & JOHNSON SURGICAL VISION, INC.; rapsgatan; uppsala 751 8 2; SE 751 82
• Manufacturer Contact: somyata nagpal ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478200
• MDR Report Key: 11092673
• MDR Text Key: 224313269
• Report Number: 3004750704-2020-00076
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TH85ML
• Device Catalogue Number: HEALON PRO
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1