MAUDE Adverse Event Report: IRIDEX CORPORATION IRIDEX IQ532 LASER CONSOLE

Model Number	65500-D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	10/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
An adverse event was reported to iridex where five days after undergoing treatment for central serous retinopathy using the iridex laser console iq532 with the slit lamp adapter (sla) and the subthreshold micropulse laser photocoagulation technique, a patient experienced worsened visual acuity with a large area of coagulation and scotoma noted.It should be noted that the patient demonstrated improved visual acuity immediately after the procedure was performed, with no device malfunction nor treatment deviation immediately following the procedure.The physician further reported that the parameters used to treat the patient were within the range as described in the operator manual of the device (300 mw micropulse duty cycle, 300 ms duration, 145 intervals, and a total of 102 laser shots administered using a single-shot gris pattern).No blanching, coagulation, subconjunctival hemorrhage, or intraoperative bleeding was observed during either the test applications or the primary treatment.No pigmented lesions or areas of increased pigmentation were present in the surgical field.At the one-week postoperative visit, the patient's va had decreased to 20/50, and clinical examination revealed evidence of tissue coagulation despite none having been noted intraoperatively.Over the subsequent weeks, the patient's vision deteriorated rapidly, and by (b)(6) 2025, va had declined to counting fingers at 3 feet.A large area of retinal coagulation and an associated enlarged scotoma were documented during follow-up.Post-incident central macular thickness increased to 289 m.The investigation supports that the event reflects a patient-specific response rather than device malfunction or use error.In a review of risk documentation, it was verified that loss of visual acuity and scotoma are known risks, and no new risk or hazard are associated with this event (i.E., the adverse event was an anticipated event).Based on the available information, the event appears to represent a patient-specific physiological response and is consistent with known risks associated with laser photocoagulation.Csr is a structural abnormality of the retina and is within the indicated use, which includes photocoagulation of structural abnormalities of the retina.Loss of visual acuity is a known risk of traditional laser photocoagulation for central serous retinopathy (csr).The procedure works by creating a deliberate, small burn on the retina, which can lead to permanent blind spots (scotoma), decreased contrast sensitivity, or, if performed too close to the fovea, reduced central vision.However, the use of subthreshold micropulse laser parameters is intended to reduce the risk of scotoma compared to the use of continuous wave laser delivery.

• Brand Name: IRIDEX IQ532 LASER CONSOLE
• Common Device Name: IQ532 LASER CONSOLE
• Manufacturer (Section D): IRIDEX CORPORATION; 1212 terra bella avenue; mountain view CA 94043 1824
• Manufacturer (Section G): IRIDEX CORPORATION; 1212 terra bella avenue; mountain view CA 94043 1824
• Manufacturer Contact: bill hyatt ; 1212 terra bella avenue; mountain view, CA 94043-1824 ; 6506058727
• MDR Report Key: 24185371
• Report Number: 2939653-2026-00001
• Device Sequence Number: 15968887
• Product Code: GEX
• UDI-Device Identifier: 00813125016258
• UDI-Public: 00813125016258
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K071687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/26/2026

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
• Device Model Number: 65500-D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 28 YR
• Patient Sex: Female