MAUDE Adverse Event Report: IRIDEX CORPORATION CUST CYCLO G6; LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intraocular Pressure Decreased (4468); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
Iridex became aware of an adverse event from literature review.A study was conducted to evaluate the safety and effectiveness of the micropulse cyclophotocoagulation on 167 eyes with various types and stages of glaucoma.The article states that the procedure lowered iop in the short term, sixty-three percent of the patients required additional iop lowering intervention.Forty-seven percent of the patients required additional iop lowering intervention.Mydriasis had not resolved in nearly two thirds who developed this complication.This study specifically noted two cases of persistent mydriasis following treatment.Iridex previously became aware of these two instances through direct report from the physician.These adverse events were reported.Engineering failure analysis could not be performed because no devices were returned to iridex.Results of complaint history review indicate that this issue is not occurring with an increased frequency or severity.Literature reference: "micropulse cyclophotocoagulation: a multicenter study of efficacy, safety, and factors associated with increased risk of complications - pubmed." pubmed, https://pubmed.Ncbi.Nlm.Nih.Gov/32852377/.

• Brand Name: CUST CYCLO G6
• Common Device Name: LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF
• Manufacturer (Section D): IRIDEX CORPORATION; 1212 terra bella ave.; mountain view CA 94043 1824
• MDR Report Key: 12264025
• Report Number: 2939653-2021-00008
• Device Sequence Number: 5061534
• Product Code: HQF
• UDI-Device Identifier: 00813125016555
• UDI-Public: 0100813125016555
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/02/2021
• 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: Other