MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY MALYUGIN RING

Model Number MALYUGIN RING

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problem Eye Injury (1845)

Event Date 08/11/2014

Event Type  malfunction  

Event Description

Malyugin ring was placed during cataract surgery.A malyugin ring breakage occurred upon removal from the eye.Damage to lenticular zonules and capsule occurred.Dislocation of iol was noted postoperatively.

• Brand Name: MALYUGIN RING
• Manufacturer (Section D): MICROSURGICAL TECHNOLOGY; redmond 98052
• MDR Report Key: 4092936
• MDR Text Key: 20325716
• Report Number: MW5038169
• Device Sequence Number: 1
• Product Code: HNQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2017
• Device Model Number: MALYUGIN RING
• Device Lot Number: 061104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 99