MAUDE Adverse Event Report: IRIDEX CORPORATION IRIS G-PROBE

Model Number	15980
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	08/23/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Nurse for a continuous wave (cw) procedure and plugged in a g-probe delivery device; the procedure was intended to be performed in micropulse mode.The physician accepted the g-probe from the nurse and treated the patients.The cyclo g6 console settings were: 2000mw / 2000ms / 250 interval.The physician did notice a difference in delivery device (mp3 probe compared to a g-probe) and decided to proceed with the procedure.While the treating physician was sweeping the superior aspect of the eye, in continuous wave mode, he began to see conjunctival shrinkage and scleral burns occur.He treated for a duration of 50 seconds total over many spots despite noting complications continued to treat the inferior aspect of the eye in the same manner.After the procedure was completed, and the physician questioned the nurse and realized the delivery devices were used in error.At follow-up on (b)(6) 2018, patient was doing well had an intra-ocular pressure (iop) of 14mmhg and a large sub-conjunctival hemorrhage present at examination in the superior aspect.The treating physician was unable to visualize the sclera.The inferior aspect of the eye was within normal limits.The patient had a fair amount of anterior chamber cell and flare and the patient's steroid drops were increased.At follow-up in (b)(6) the patient showed improvement, the visual acuity went from 20/400 to 20/200 and iop went from 50 to 22.There are no indications the devices did not function as expected.The device history record for the cyclo g6 console was reviewed and there were no anomalies found.Iridex does not expect to receive the devices back for evaluation; in the event the devices are returned this report will be updated.

• Brand Name: IRIS G-PROBE
• Common Device Name: IRIS G-PROBE
• Manufacturer (Section D): IRIDEX CORPORATION; 1212 terra bella avenue; mountain view CA 94043 1824
• MDR Report Key: 7900087
• Report Number: 2939653-2018-00012
• Device Sequence Number: 13789694
• Product Code: GEX
• UDI-Device Identifier: 00813125015237
• UDI-Public: (01)00813125015237
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143154
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 15980
• Device Catalogue Number: 15980
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR