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

Model Number	TG85ML
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth, weight, ethnicity: unknown/not provided.Date of event: unknown, not provided.If implanted; give date: n/a (not applicable).The healon gv pro is not an implantable device.If explanted; give date: n/a (not applicable).The healon gv pro is not an implantable device.Telephone number: (b)(6).The intraocular lens (iol) is not returning for evaluation as it was disposed; 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.
Event or Problem Description
The customer reported cannulas are coming either completely clogged or partially clogged and we are not able to advance the viscoelastic during priming or during procedures.M.D.Has a hard time filling the eye because of the partial clog.They have disposed of the cannulas.No patient injury reported.No other information was provided.

• Brand Name: HEALON GV 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: 12164450
• Report Number: 3004750704-2021-07054
• Device Sequence Number: 19821379
• Product Code: LZP
• UDI-Device Identifier: 05050474651654
• UDI-Public: (01)05050474651654(17)240131(10)UJ31048
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/13/2021

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: 01/31/2024
• Device Model Number: TG85ML
• Device Catalogue Number: 10240014
• Device Lot Number: UJ31048
• 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: 06/15/2021
• Initial Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1