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 08/17/2020

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.If implanted; give date: n/a (not applicable).The device is not an implantable device.If explanted; give date: n/a (not applicable).The device is not an implantable device; therefore, not explanted.Phone number: (b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that white solid particle was observed when the doctor attempted to use the product.The doctor stopped using the device.Procedure was successfully completed with a backup product.There was no patient injury reported.It was indicated that the white fibrous matter was observed while healon was injected into the anterior capsule.It was immediately removed from patient's eye.There was no patient injury reported.No further information was provided.

Manufacturer Narrative

Section d10.Device available for evaluation? yes; returned to manufacturer on: 9/28/2020.Section h3.Device returned to manufacturer? yes.Device evaluation: the sample was received at the manufacturing site for further evaluation.Visual inspection was performed, and no white particles were observed.The reported event cannot be confirmed.The manufacturing process record was evaluated, and no deviation was found during process related to the complaint issue reported.The product was manufactured and released according to specifications.A search in the complaint system revealed that no complaints have previously been reported on this batch.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 has been submitted.

• 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
• MDR Report Key: 10536391
• MDR Text Key: 207038425
• Report Number: 3004750704-2020-00045
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 04987617203481
• UDI-Public: (01)04987617203481(17)221130(10)UE31811
• 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
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2022
• Device Model Number: TH85ML
• Device Catalogue Number: 10260012
• Device Lot Number: UE31811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1