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 Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Irdex became aware of an adverse events from literature review involving cases of hyphema,choroidal effusion and persistent mydriasis.A study was conducted in 95 patients to evaluate the safety and effectiveness of double-session micropulse transscleral laser (mp3) as a primary treatment modality for glaucoma.The article mentions that all patients had significant intraocular pressure-lowering compared to baseline and the success was achieved with one treatment in 76.8% patients.No specific followup details or patient information was available in relationship to the patients who experienced the adverse events.The article concludes that micropulse transscleral cyclophotocoagulation is a safe and efficacious treatment for glaucoma.No devices were returned to iridex so engineering failure analysis could not be performed.A definitive root cause for the adverse events could not be determined based on the information provided.The iridex biomedical engineer completed a review of complaint history to identify and review similar events.Based on the results of review, it does not appear that these events are occuring with an increased frequency or severity.Literature reference: early results of micropulse transscleral cyclophotocoagulation for the treatment of glaucoma - pubmed." pubmed, https://pubmed.Ncbi.Nlm.Nih.Gov/30938190/.

• 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: 12264054
• Report Number: 2939653-2021-00007
• Device Sequence Number: 5061533
• 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