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.(b)(6).Device evaluation by mfr: the product is not returning for evaluation as it was discarded by the customer; therefore, no further investigation can be performed.If there is any further relevant information received, a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that something like fiber came out in the patient's eye when pushed to the end.The suspect product was discarded at the customer facility.There was no patient injury reported.No additional information was provided.

Manufacturer Narrative

Additional information: new information received clarified that the lot number (ue31075) that was initially provided by the customer is not a valid lot number.Additional follow up indicated that the actual lot number is unknown.Corrected data: since the incorrect lot number (ue31075) was entered in the initial mdr report.Therefore, the information has been corrected in this supplemental mdr report.Catalog number: a complete catalog number is unknown, as the lot number was not provided.Expiration date: unknown, as the lot number was not provided.Lot number: unknown, information not provided.Udi #: a complete udi # is unknown as product lot number was not provided.Device manufacture date: unknown, as the lot number was not provided.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 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 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: 8939056
• MDR Text Key: 176417200
• Report Number: 3004750704-2019-00021
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Public: (01)(17)190406(10)UE31075
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2019
• Device Model Number: TH85ML
• 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
• Initial Date Manufacturer Received: 08/03/2019
• Initial Date FDA Received: 08/28/2019
• Supplement Dates Manufacturer Received: 10/22/2019; 10/25/2020
• Supplement Dates FDA Received: 11/15/2019; 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1