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

Model Number UNKNOWN

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

Patient Problems Hyphema (1911); Intraocular Pressure Decreased (4468)

Event Date 04/14/2022

Event Type  Injury  

Manufacturer Narrative

Age (mos): at disease onset:

Event Description

The following article was received based on a literature review: article: viscocanalostomy combined with trabeculotomy for management of refractory primary congenital glaucoma.A prospective study was done to investigate the outcome of viscocanalostomy combined with trabeculotomy (vco+tbo) in primary congenital glaucoma (pcg) with history of failed trabeculotomy.A total of 46 patients (n=75 eyes) were enrolled in the study.The procedure included a deep scleral flap incision, wherein high-molecular-weight sodium hyaluronate (healon gv, pfizer, new york, ny) was injected into the ostia of schlemm¿s canal using a 30-gauge cannula.After trabeculotomy, the superficial scleral flap and conjunctiva were then tightly sutured back using 8-0 polyglactin 910 sutures.Finally, the anterior chamber was irrigated and reformed with balanced salt solution.Reported complication included hyphema (b)(4) eyes) which resolved spontaneously in all cases.At the last follow-up, there were failures (n= 31 eyes); one failure, which was due to hypotony caused by formation of iatrogenic cyclodialysis (b)(4) eye) which was repaired surgically after 1 month of treatment with cycloplegic agents.There were no further interventions reported.

• Brand Name: HEALON GV 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 ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15706251
• MDR Text Key: 302777422
• Report Number: 3012236936-2022-02667
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: IR
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• 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: 10/07/2022
• 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