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

Model Number	10240012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Edema (1791); Intraocular Pressure Increased (1937); Visual Impairment (2138); Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	06/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted; give date: n/a (not applicable).The healon pro is not an implantable device.If explanted; give date: n/a (not applicable).The healon pro is not an implantable device.Manufacturer telephone number: (b)(4).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 there were 6 cases of toxic anterior segment syndrome (tass).It was learned that for this event, the visual symptoms presented with significant vision loss, corneal edema right eye and elevated intraocular pressure (iop).Treatment provided was intensive topical steroids, topical glaucoma drops cosopt 2x/day.The following meds were also given but was noted as the doctor's standard care, durezol every 2 hrs.Hours tapered to 4 x day, cosopt 2x/day, prolensa everyday , moxifloxacin 2x/day.It was stated that current patient status is edema and inflammation resolving, best corrected visual acuity (bcva) 20/25 but expected to continue to improve.Intraocular lens (iol) remains implanted.No additional medical or surgical intervention required.The other products are not being returned for evaluation.Additional information received noted that the customer investigated the cases.However, root cause for the tass has not been determined.No other information was provided.This report is 3 of 6 cases for tass capturing the event for the healon pro.Separate reports are being submitted for each of the other products involved.

• Brand Name: HEALON PRO
• Common Device Name: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): AMO UPPSALA AB; rapsgatan 7; uppsala, uppsala län 754 5 0; SW 754 50
• MDR Report Key: 12200532
• Report Number: 3004750704-2021-07062
• Device Sequence Number: 5127800
• Product Code: LZP
• UDI-Device Identifier: 05050474636989
• UDI-Public: (01)05050474636989(17)240228(10)UJ31114
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P810031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2024
• Device Model Number: 10240012
• Device Catalogue Number: 10240012
• Device Lot Number: UJ31114
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 77