MAUDE Adverse Event Report: IRIDEX CORPORATION MICROPULSE P3 DEVICE (MP3 PROBE); POWERED LASER SURGICAL INSTRUMENT

Model Number 15522

Device Problems Defective Device (2588); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems Corneal Abrasion (1789); Eye Injury (1845)

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

The tip of the fiberoptic cable protrudes too far beyond the probe tip, which can cause abrasion of the conjunctiva during laser delivery to the eye.

Event Description

During use of the iridex mp3 probe, a conjunctival abrasion/laceration of the eye was observed.The physician reported an imperfection of the mp3 probe tip as the cause of the abrasion/laceration.

• Brand Name: MICROPULSE P3 DEVICE (MP3 PROBE)
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): IRIDEX CORPORATION; 1212 terra bella avenue; mountain view CA 94043 1824
• Manufacturer (Section G): IRIDEX CORPORATION; 1212 terra bella ave.; mountain view CA 94043 1824
• Manufacturer Contact: edward sinclair ; 1212 terra bella ave.; mountain view, CA 94043-1824 ; 6502189149
• MDR Report Key: 7138807
• MDR Text Key: 95967512
• Report Number: 2939653-2017-00016
• Device Sequence Number: 0
• Product Code: HQF
• Combination Product (y/n): N
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/26/2020
• Device Model Number: 15522
• Device Catalogue Number: 15522
• Device Lot Number: 016710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2017
• 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
• Patient Age: 60 YR