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

Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	01/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Iridex became aware of a complaint reporting 3 scleral burns following treatment with slx laser console and g-probe delivery device.Minimal information was provided by the customer with respect to potential causes of the events or the performance of the laser console and the delivery device.The customer call record indicated that the following treatment parameters were used 1250mw, 2000ms.No other information was provided with the call record.The devices have not been returned for evaluation.The customer has not responded to request for additional information.Iridex will continue to follow up and attempt to get additional information related to the event.At this time, it is not possible to determine the root cause of the issue and it is not known if the scleral burns reported affected a single patient or multiple patients.An amended report will be submitted if additional information is available.
Event or Problem Description
Iridex became aware of a patient experiencing 3 scleral burns following treatment with slx laser console and g-probe delivery device.All 3 burns occurred on one the patient during a single treatment.The complainant checked and confirmed that the laser console was functioning within specifications,with treatment parameters of 1250mw, 2000ms.The g-probe used for treatment was discarded by the customer and was not provided to iridex for further investigation.
Additional Manufacturer Narrative
This follow-up report is provided to update the following: 1)part b: b5 -product problem section was updated.2) report c: is this a combination product - no.3) report d: updates to section d1,d4,d8, d9, d4.4) part h: update to include that this a correction and additional information report.5) part d: updated this section with the udi number.6) part e: updates to the initial reporter section with information regarding the complainant.Note: patient information was not provided, therefore part a is not filled out.

• Brand Name: G-PROBE
• Common Device Name: LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF
• Manufacturer (Section D): IRIDEX CORPORATION; 1212 terra bella ave.; mountain view CA 94043 1824
• Manufacturer (Section G): IRIDEX CORPORATION; 1212 terra bella ave; mountain view CA 94043 9149
• Manufacturer Contact: madhumita srikanth ; 1212 terra bella ave; mountain view, CA 94043-9149 ; 6502189149
• MDR Report Key: 13446775
• Report Number: 2939653-2022-00002
• Device Sequence Number: 4304688
• Product Code: HQF
• UDI-Device Identifier: 00813125015350
• UDI-Public: 00813125015350
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K020374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2024

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
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Sex: Unknown