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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); 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 investigate the clinical efficacy and safety profile of micropulse transscleral cyclophotocoagulation (mp-cpc) in patients with refractory glaucoma.The study noted 2 patients with phthisis,7 patients with hypotony and 13 patient with loss of visual acuity after micropulse transscleral cyclophotocoagulation.The study concluded that mp-cpc is an effective treatment for patients with refractory glaucoma and that shorter treatment times with more frequent repeat treatments may be considered given the incidence of significant vision loss in this study.No patient followup information has been provided in the article.Literature reference: "clinical efficacy and safety profile of micropulse transscleral cyclophotocoagulation in refractory glaucoma - pubmed." pubmed, https://pubmed.Ncbi.Nlm.Nih.Gov/29521718/.

• 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: 12264051
• Report Number: 2939653-2021-00005
• Device Sequence Number: 17408605
• 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