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

Model Number HEALON DUET

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

Patient Problem Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.Date of event: unknown, not provided.Expiration date: unknown, as the lot number was not provided.Lot number: unknown, information not provided.Udi number: unknown, as the lot number was not provided.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.Concomitant medical products: information provided indicates the concomitant lens is possibly a model zcb00, za9003, or alcon lens (non-j&j device) as these are the type of iols that were mostly used.Device manufacture date: unknown, as the serial number was not provided.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 Description

It was reported that a doctor has had a case of toxic anterior segment syndrome (tass) within the last couple of months and they are very concerned.It was learned that the customer cannot attribute it to a specific product, however, the use of ophthalmic viscosurgical device (ovd) healon duet was mentioned.No suspect product returning.Patient treated with antibiotics and vision improved.No other information was provided.

• Brand Name: HEALON DUET
• 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: 10932933
• MDR Text Key: 219138598
• Report Number: 3004750704-2020-00059
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HEALON DUET
• Device Catalogue Number: HEALON DUET
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention