MAUDE Adverse Event Report: IRIDEX CORPORATION CUST-IQ577; LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF

Device Problem Use of Device Problem (1670)

Patient Problem Eye Burn (2523)

Event Date 05/05/2021

Event Type  Injury  

Event Description

Iridex became aware of a complaint reporting a patient experiencing macular burn that developed into a macular scar during macular laser treatment for diabetic maculopathy.The laser console's present menu was not configured with the specific power setting and duty cycle that the physician intended for this treatment.The physician manually programmed the treatment settings and inadvertently put the console into continuous wave mode vs.The intended selection of micropulse mode.The treatment was performed in continuous wave mode and the patient suffered a macular burn as a result of over treatment.The physician reported dissatisfaction with the graphical user interface (gui) and the absence of a preprogrammed preset option with a power setting of 200-250mw.Preset options are fully programmable and can be modified and adjusted according to treatment requirements by the physician.The iq577 laser system operator manual pages 17-23 provides instructions to the user regarding the preset options including how to select a preset and how to program a preset option.Based on the information provided, it does not appear the surgeon understood that the preset options are fully programmable.Page 10 of the operator manual includes the following warning 'lasers generate a highly concentrated beam of light that may cause injury if improperly used.To protect the patient and the operating personnel, the entire laser and the appropriate delivery systemoperator manuals should be carefully read and comprehended before operation.' this issue is not a part of an increasing trend and the iq lasers have a strong track record for safety and reliability.

Event Description

Follow up report: 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: updated this section with the udi number.5) part e: updates to the initial reporter section with infromation regarding the complainant.The following text were provided in the initial report: iridex became aware of a complaint reporting a patient experiencing macular burn that developed into a macular scar during macular laser treatment for diabetic maculopathy.The laser console's present menu was not configured with the specific power setting and duty cycle that the physician intended for this treatment.The physician manually programmed the treatment settings and inadvertently put the console into continuous wave mode vs.The intended selection of micropulse mode.The treatment was performed in continuous wave mode and the patient suffered a macular burn as a result of over treatment.The physician reported dissatisfaction with the graphical user interface (gui) and the absence of a preprogrammed preset option with a power setting of 200-250mw.Preset options are fully programmable and can be modified and adjusted according to treatment requirements by the physician.The iq577 laser system operator manual pages 17-23 provides instructions to the user regarding the preset options including how to select a preset and how to program a preset option.Based on the information provided, it does not appear the surgeon understood that the preset options are fully programmable.Page 10 of the operator manual includes the following warning 'lasers generate a highly concentrated beam of light that may cause injury if improperly used.To protect the patient and the operating personnel, the entire laser and the appropriate delivery systemoperator manuals should be carefully read and comprehended before operation.' this issue is not a part of an increasing trend and the iq lasers have a strong track record for safety and reliability.

• Brand Name: CUST-IQ577
• 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: 11941014
• MDR Text Key: 254333470
• Report Number: 2939653-2021-00014
• Device Sequence Number: 1
• Product Code: HQF
• 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: 06/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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