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

Model Number TH85ML

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hyphema (1911); Intraocular Pressure Increased (1937); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.Date of event: exact date unknown, around 20 days prior to the (b)(6) 2020.Catalog #, serial/lot#, udi# and expiration date: unknown/not provided.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.Reporter phone: (b)(6).Device manufacture date: unknown as serial number was not provided.(b)(4).Device evaluation: the healon unit was not returned for evaluation.Therefore, a failure analysis of the complaint device could not be performed.Manufacturing record evaluation: the manufacturing records for the product could not be reviewed since no lot/serial details could be obtained.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the surgeon noticed an increase of post-operative intraocular pressure (iop) and a small hemorrhagic bleeding requiring medication to release the pressure from the eye.The surgeon did procedures as usual and could not confirm what caused the incident, but he was trying now to avoid future problems.Through follow-up we learnt that the exact incident date is not known but is thought to be about 2 weeks prior to the report being made to johnson & johnson vision.The customer is not sure our product was the cause.The exact lot number is also unclear and cannot be provided.The patient was treated with medication.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 (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: 10365242
• MDR Text Key: 203312875
• Report Number: 3004750704-2020-00040
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): Y
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TH85ML
• 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
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention