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

Model Number	HEALON ENDOCOAT
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: n/a (not applicable).The healon duet is not an implantable device.If explanted; give date: n/a (not applicable).The healon duet is not an implantable device.Device evaluation by mfr: the device is not returning for evaluation as it was discarded by the account; therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and complaint trending 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 & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a surgeon observed ''white fiber'' when injecting healon duet pro ophthalmic viscosurgical device (ovd).The white fiber was removed by irrigation and aspiration.There was no patient adverse event reported by the surgeon.Through follow-up it was clarified that the doctor did not observe the white fiber inside of the ovd.However, when the doctor injected the visco device, he observed the white fiber in the patient's eye.Hence, the doctor concluded that the white fiber may have come from the healon duet pro.Doctor was able to remove the white fiber by irrigation and aspiration.The patient was fine post-op, surgery went well.It was noted there will be no product returned, and no debris available for evaluation.
Additional Manufacturer Narrative
Corrected data: upon further review, it was learned that the specific suspect product endocoat has a confirmed lot number.Therefore, this correction mdr is being submitted.Brand name: healon endocoat.Model number: healon endocoat.Lot#: 027851.Catalog#: 57502000.Expiration date: 1/31/2021.Udi #: (b)(4).Device manufacture date: 2/14/2019.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional 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 DUET PRO
• Common Device Name: OVDS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9169893
• Report Number: 3004750704-2019-00043
• Device Sequence Number: 19523630
• Product Code: LZP
• UDI-Device Identifier: 05050474651425
• UDI-Public: (01)05050474651425(17)210131(10)UE31411
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P110007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2020
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: HEALON ENDOCOAT
• Device Catalogue Number: 57502000
• Device Lot Number: 027851
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/13/2019
• Supplement Date Received by Manufacturer: 10/10/2019; 10/25/2020
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 11/01/2019; 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Date Report Sent to FDA: 01/01/2005