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 Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.Date of event: unknown, not provided.If implanted; give date: n/a (not applicable).The healon pro is not an implantable device.If explanted; give date: n/a (not applicable).The healon pro is not an implantable device; therefore, not explanted.Initial reporter name: unknown, not provided.(b)(6).Device evaluation: per visual inspection of the material find, the gray fiber was determined to be cellulose (cotton).However, the source of the fiber is unable to be determined.Furthermore, no other similar complaints related to this lot number has been reported.Johnson & johnson surgical vision will continue to monitor this type of complaints.Manufacturing records review: manufacturing record review for product was performed and no deviation related to this complaint was found.All results were within specification and no similar complaints have previously been reported on this batch.Conclusion: as a result of the investigation, the complaint was confirmed; however, no definite conclusion can be made as to the root-cause of this issue.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a material came out into the patient's eye with the healon pro device, model th85ml.The material was removed during same procedure; therefore, no treatment was required.There was no patient injury was reported.No additional information was provided.

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 nr-0148919 and capa-010215.

• 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: 8900089
• MDR Text Key: 176416681
• Report Number: 3004750704-2019-00019
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 04987617203481
• UDI-Public: (01)04987617203481(17)211231(10)UE30965
• 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: 01/01/2005,11/12/2020

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: 12/31/2021
• Device Model Number: TH85ML
• Device Catalogue Number: 10260012
• Device Lot Number: UE30965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• 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: 05/10/2019
• Initial Date FDA Received: 08/15/2019
• Supplement Dates Manufacturer Received: 10/25/2020
• Supplement Dates FDA Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1