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

Model Number TH85ML

Device Problem Contamination (1120)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.Date of event: exact date unknown.If implanted; give date: the viscoelastic, healon pro is not an implantable device.If explanted; give date: the viscoelastic, healon pro is not an implantable device.Therefore, not explanted.Last name: unknown/ not provided.Phone: (b)(6).The viscoelastic healon pro is not returning for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, labeling, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information 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 fibers were found in between 5/10 units of healon pro th85ml.It was also reported that some of the patients where found to have fiber stuck within the incision during the post op examination.Customer is not sure that it is coming from the healon pro as the fiber could come from the table setting for surgeries.No inflammations or patient injuries were reported so far.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: 10536320
• MDR Text Key: 207217250
• Report Number: 3004750704-2020-00044
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474609662
• UDI-Public: (01)05050474609662(17)230131(10)UH31072
• Combination Product (y/n): Y
• Reporter Country Code: DK
• 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: 09/15/2020

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: 01/31/2023
• Device Model Number: TH85ML
• Device Catalogue Number: 10271012
• Device Lot Number: UH31072
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/29/2020
• 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