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 02/14/2023

Event Type  Injury  

Event 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 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
• 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: 16818112
• MDR Text Key: 314038720
• Report Number: 2939653-2023-00002
• Device Sequence Number: 1
• Product Code: HQF
• UDI-Device Identifier: 00813125016630
• UDI-Public: 813125016630
• 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
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2023
• 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