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

Model Number 15522

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Eye Burn (2523)

Event Date 03/17/2023

Event Type  Injury  

Event Description

Iridex became aware of a patient experiencing mild conjunctival during treatment with a cyclo g6 laser system in combination with the micropulse p3 probe.The treatment settings used were within the recommended settings.A definitive root cause could not be determined, and no additional information has been provided by the clinic or treating physician.Engineering failure analysis could not be performed because the device was not returned for evaluation.No additional information is available at this moment.Iridex will continue to follow-up with the doctor for information regarding patient recovery.

Event 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, d9.3) 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 infromation 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 mild conjunctival during treatment with a cyclo g6 laser system in combination with the micropulse p3 probe.The treatment settings used were within the recommended settings.A definitive root cause could not be determined, and no additional information has been provided by the clinic or treating physician.Engineering failure analysis could not be performed because the device was not returned for evaluation.No additional information is available at this moment.Iridex will continue to follow-up with the doctor for information regarding patient recovery.

• Brand Name: MICROPULSE P3
• Type of Device: 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: 16820114
• MDR Text Key: 314055309
• Report Number: 2939653-2023-00004
• Device Sequence Number: 1
• Product Code: HQF
• UDI-Device Identifier: 00813125016647
• UDI-Public: 00813125016647
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K143154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 15522
• Device Lot Number: 800773
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other