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	03/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Iridex became aware of a patient experiencing conjunctival burn during treatment with a micropulse p3 probe and cyclo g6 laser system.Based on the information provided, it appears the treatment was performed within specifications.Engineering failure analysis could not be performed because the device was not returned for evaluation.A definitive root cause could not be determined, and no additional information has been provided by the clinic or treating physician.Iridex made attempts to follow up and gather additional information but all attempts were unsuccessful.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.
Event or Problem Description
Part a is not filled out as patient identifier details were not provide to iridex.This report has been created to make corrections to the previous report.The changes include: 1) report c: is this a combination product - no 2) report d: updates to section d8, d9.Device details updated from cyclo g6 to micropulse p3 in section d1.3) part h: update to include that this a correction report 4) part d: update the lot number information.The lot number was filled out in the section for serial number.Updated this section with the udi number.5) part e: updates to the initial reporter section with information regarding the complainant 6) part h4: updates to date of manufacture.This information was not submitted previously the following text were provided in the initial report: iridex became aware of a patient experiencing conjunctival burn during treatment with a micropulse p3 probe and cyclo g6 laser system.Based on the information provided, it appears the treatment was performed within specifications.Engineering failure analysis could not be performed because the device was not returned for evaluation.A definitive root cause could not be determined, and no additional information has been provided by the clinic or treating physician.Iridex made attempts to follow up and gather additional information but all attempts were unsuccessful.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.

• 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 94043-1824 ; 6502189149
• MDR Report Key: 14277759
• Report Number: 2939653-2022-00010
• Device Sequence Number: 4841545
• 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): 10/04/2023

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
• Device Lot Number: 870028
• 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: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2021
• 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