MAUDE Adverse Event Report: AMO UPPSALA AB HEALON PRO; AID, SURGICAL, VISCOELASTIC

Model Number TH85ML

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2021

Event Type  malfunction  

Event Description

It was reported that during a cataract surgery, when the capsule was inflated, before an intraocular lens (iol) was inserted, a fibrous substance was observed which seemed to have come out of the syringe needle of the healon device.The foreign substance was taken out of the eye and the iol was inserted to close the surgery.The post-op evaluation conducted the day after the surgery revealed no inflammation.The used healon and the substance were discarded.Later, it was indicated that it is unlikely that the substance entered the eye via the syringe needle as the remainder in the syringe since the healon was used at the setting stage of the iol to the cartridge, before the capsule was inflated.There was no patient injury reported.No further information was provided.

Manufacturer Narrative

If implanted, give date: not applicable, the healon is not an implanted product.If explanted, give date: not applicable, the healon is not an implanted product.(b)(6).The device is not returning for evaluation as it was discarded; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, 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 & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected data: in review, it was noted that the patient's race and ethnicity was inadvertently not entered in the initial mdr report; therefore, the information has been captured in this supplemental mdr report and the following fields were updated accordingly: section a5: ethnicity: not hispanic/latino.Section a5: race: asian.Additional information: additional information received indicated that the customer did not make a specific comment about the source of the fibrous substance, but they suspected that the the fibrous substance came from healon.Screen captured images and a video of the procedure were provided by the customer.Evaluation of the provided media shows a fiber strand within the eye.The reported foreign material issue is confirmed.The composition of the foreign material, whether cellulose or hair, cannot be determined through video.Per initial report, both the healon and the foreign material were discarded and are not available for analysis.No root cause can be determined as the foreign material could have been a result from a contamination at customer site.No cellulose is used within the production method.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: HEALON PRO
• Type of Device: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): AMO UPPSALA AB; rapsgatan 7; uppsala, uppsala län 754 5 0; SW 754 50
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12843971
• MDR Text Key: 281144582
• Report Number: 2020664-2021-08169
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TH85ML
• Device Catalogue Number: 10260012
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2021
• 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 Ethnicity: Non Hispanic
• Patient Race: Asian