MAUDE Adverse Event Report: IRIDEX CORPORATION CYCLO G6; LASER SYSTEM; GEX

Catalog Number	66245-1
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	01/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event occurred when using an iridex cyclo g6 laser console with a micropulse p3 (mp3) laser delivery probe.Since neither device can be ruled out at the time of this mdr submission, iridex is reporting the cyclo g6 under mfr report and the mp3 probe under mdr 2939653-2019-00001.
Event or Problem Description
Iridex received a report of scleral laceration following use of a micropulse (mp3) probe with the cyclo g6 laser console.The physician reported that the laceration appeared to reach almost all layers of the sclera.The patient in this case was undergoing a second micropulse transscleral cyclophotocoagulation treatment (mp-tscps) following initial treatment three months prior.The laser settings were within the recommended settings, 2000mw and the physician indicated that the upper and lower hemisphere of the left eye were reciprocated twice for 20 seconds in each direction.The physician reported that the patient was experiencing significant subconjunctival bleeding at the anesthesia injection site prior to receiving treatment.The physician performed the treatment and discharged the patient.The damaged scleral tissue was observed at the patient's 1-day post-operative follow up at which time the patient was hospitalized to treat the injury, reportedly with "a suture".The report was provided by iridex's distributor on behalf of the attending physician.

• Brand Name: CYCLO G6
• Common Device Name: LASER SYSTEM; GEX
• Manufacturer (Section D): IRIDEX CORPORATION; 1212 terra bella avenue; mountain view CA 94043 1824
• MDR Report Key: 8339298
• Report Number: 2939653-2019-00002
• Device Sequence Number: 2229557
• Product Code: GEX
• UDI-Device Identifier: 00813125016555
• UDI-Public: 0100813125016555
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143154
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2019

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 Catalogue Number: 66245-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/14/2019
• 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