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

Model Number	15522
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	03/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Iridex became aware of a complaint reporting that the tip of the probe began emitting smoke during the procedure.The procedure was performed using a micropulse p3 probe and cyclo g6 laser system.It was noted before the procedure that patient had lightly pigmented conjunctiva.Pigmented conjunctiva presents a known procedural risk because the pigmented tissue can absorb the laser energy and increase the chance of a tissue burn occurring.In this case, the doctor reported that smoke was observed coming from the tip of the device at the beginning of treatment.The doctor aborted the procedure after this observation.A conjunctival burn was observed, and the doctor performed treatment for the burn.The most likely cause of this event is the activation of the laser over the areas pigmented conjunctiva.After activation, some tissue was transferred to the device tip and the laser was activated again resulting in the "smoking tip".The ifu provides instructions to the user to examine the tip of the device to make sure no blood or other contaminants are present.Per the ifu contamination of the fiber optic tip by blood or tissue char may result in ocular surface burns.Heavy perilimbal conjunctival pigmentation may result in local absorption and burns; therefore, avoid areas of heavy perilimbal pigmentation.The manufacturing device history records were reviewed, and no anomalies or issues were identified.The results of post market data review suggest that this failure mode is not occurring with greater severity or frequency based on the number of events reported evaluated against the number of cases performed.
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 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.
Event or Problem Description
Iridex became aware of a complaint reporting that the tip of the probe began emitting smoke during the procedure.The procedure was performed using a micropulse p3 probe and cyclo g6 laser system.It was noted before the procedure that patient had lightly pigmented conjunctiva.Pigmented conjunctiva presents a known procedural risk because the pigmented tissue can absorb the laser energy and increase the chance of a tissue burn occurring.In this case, the doctor reported that smoke was observed coming from the tip of the device at the beginning of treatment.The doctor aborted the procedure after this observation.A conjunctival burn was observed, and the doctor performed treatment for the burn.The most likely cause of this event is the activation of the laser over the areas pigmented conjunctiva.After activation, some tissue was transferred to the device tip and the laser was activated again resulting in the "smoking tip".The ifu provides instructions to the user to examine the tip of the device to make sure no blood or other contaminants are present.Per the ifu "contamination of the fiber optic tip by blood or tissue char may result in ocular surface burns.Heavy perilimbal conjunctival pigmentation may result in local absorption and burns; therefore, avoid areas of heavy perilimbal pigmentation".

• Brand Name: MICROPULSE 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
• 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: 14277485
• Report Number: 2939653-2022-00011
• Device Sequence Number: 14662782
• Product Code: HQF
• UDI-Device Identifier: 00813125015220
• UDI-Public: 0813125015220
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K143154
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2024

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
• Device Model Number: 15522
• 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: 05/04/2022
• 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