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

Model Number	15522
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	02/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Iridex became aware of a patient experiencing scleral burn during treatment with a micropulse p3 probe.Based on the information provided and similar adverse events, the most likely cause of the issue is suspected to be contamination on the probe tip when the laser was activated or laser activation when the probe is over pigmented conjunctival tissue.The micropulse p3 ifu has clear instructions to examine the probe tip before treatment and to avoid areas of perilimbal pigmentation.Per the ifu 'excessive treatment power may result in ocular surface burns or ciliary body hemorrhage.Contamination of the fiber optic tip by blood or tissue char may result in ocular surface burns.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.
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: report c: is this a combination product - no.Part h: update to include that this a correction report 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.Part e: updates to the initial reporter section with infromation regarding the complainant 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 scleral burn during treatment with a micropulse p3 probe.Based on the information provided and similar adverse events, the most likely cause of the issue is suspected to be contamination on the probe tip when the laser was activated or laser activation when the probe is over pigmented conjunctival tissue.The micropulse p3 ifu has clear instructions to examine the probe tip before treatment and to avoid areas of perilimbal pigmentation.Per the ifu 'excessive treatment power may result in ocular surface burns or ciliary body hemorrhage.Contamination of the fiber optic tip by blood or tissue char may result in ocular surface burns.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.

• 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
• MDR Report Key: 16818112
• Report Number: 2939653-2023-00002
• Device Sequence Number: 12557793
• Product Code: HQF
• UDI-Device Identifier: 00813125016630
• UDI-Public: 813125016630
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2023

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
• 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: 02/14/2023
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 12/11/2023
• 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