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 02/07/2023

Event Type  Injury  

Event Description

Iridex became aware of a complaint reporting a patient experiencing conjunctival burn during treatment with the micropulse p3 probe.A specific root cause could not be determined.Based on similar reported events, the most likely cause of the issue is suspected to be contamination (e.G.Blood, tissue or betadine) on the probe tip when the laser was activated or laser activation when the probe is over pigmented conjunctival tissue.Follow-up information from the surgeon indicated that the patient was recovering from the burn.Engineering failure analysis was not performed because the device was not returned for evaluation.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.Excessive energy may cause equatorial burns.Heavy perilimbal conjunctival pigmentation may result in local absorption and burns; therefore, avoid areas of heavy perilimbal pigmentation.' iridex has requested the clinic to return the laser system and the micropulse p3 probe for additional investigation but the devices have not been returned to date.If the devices are returned and the results of failure analysis indicate new information, the adverse event report will be amended.

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 e: updates to the initial reporter section with information regarding the complainant 5) 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 complaint reporting a patient experiencing conjunctival burn during treatment with the micropulse p3 probe.A specific root cause could not be determined.Based on similar reported events, the most likely cause of the issue is suspected to be contamination (e.G.Blood, tissue or betadine) on the probe tip when the laser was activated or laser activation when the probe is over pigmented conjunctival tissue.Follow-up information from the surgeon indicated that the patient was recovering from the burn.Engineering failure analysis was not performed because the device was not returned for evaluation.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.Excessive energy may cause equatorial burns.Heavy perilimbal conjunctival pigmentation may result in local absorption and burns; therefore, avoid areas of heavy perilimbal pigmentation.' iridex has requested the clinic to return the laser system and the micropulse p3 probe for additional investigation but the devices have not been returned to date.If the devices are returned and the results of failure analysis indicate new information, the adverse event report will be amended.

• 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
• Manufacturer Contact: madhumita srikanth ; 1212 terra bella ave; mountain view, CA 94043-9149 ; 6502189149
• MDR Report Key: 16456534
• MDR Text Key: 310410024
• Report Number: 2939653-2023-00001
• Device Sequence Number: 1
• Product Code: HQF
• UDI-Device Identifier: 00813125015251
• UDI-Public: 00813125015251
• 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: 11/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• 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
• 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