MAUDE Adverse Event Report: IRIDEX CORPORATION MIRCOPULSE P3; LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	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 compare the safety and efficacy of micropulse cyclophotocoagulation (mp-cpc) and transscleral continuous wave cyclophotocoagulation (cw-cpc) for the treatment of refractory glaucoma.The article discusses one case of hypotony that developed into phthisis bulbi following cw-cpc treatment.No additional patient information is available.The final conlusion of the article noted that both mp-cpc and cw-cpc provide a safe and effective treatment method for in lowering the iop in patients with refractory glaucoma.A review of complaint history was completed.Based on the results of this review, this event does not appear to be a part of an increasing trend.Because this adverse event was identified through literature review, there were no devices returned for engineering failure analysis.A definitive root cause for the event could not be determined.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: MIRCOPULSE P3
• 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: 12264027
• Report Number: 2939653-2021-00009
• Device Sequence Number: 5061535
• 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