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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2022

Event Type  Injury  

Event Description

Iridex became aware of a complaint reporting a patient experiencing a sizzle followed by a smell during treatment with the micropulse p3 probe.A specific root cause could not be determined.The doctor followed the instructions on the micropulse ifu and immediately stopped treatment with the probe.There was no patient injury reported.The treatment was performed within specifications.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.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.

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 complaint reporting a patient experiencing a sizzle followed by a smell during treatment with the micropulse p3 probe.A specific root cause could not be determined.The doctor followed the instructions on the micropulse ifu and immediately stopped treatment with the probe.There was no patient injury reported.The treatment was performed within specifications.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.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.

• 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 94043-1824 ; 6502189149
• MDR Report Key: 16456362
• MDR Text Key: 310407646
• Report Number: 2939653-2022-00036
• Device Sequence Number: 1
• Product Code: HQF
• UDI-Device Identifier: 00813125015251
• UDI-Public: 813125015251
• 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: 10/10/2023

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
• Device Lot Number: 800760
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/05/2021
• 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