MAUDE Adverse Event Report: STAAR SURGICAL COMPANY MICROSTAAR ® INJECTOR; INTRAOCULAR LENS GUIDE

Catalog Number N/A

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2016

Event Type  malfunction  

Manufacturer Narrative

Expiration date - unk.Device evaluated by manufacturer? no.(b)(4).

Event Description

The reporter stated the surgeon attempted to insert an aq2010v +05.0 silicone 3 piece lens, +05.0 diopter, and the injector would not push the lens through.There was no patient contact with the lens.The reporter stated the cause of the event was due to the injector.

Manufacturer Narrative

Visual inspection of the returned product found no visible damage to the lens.(b)(4).

• Brand Name: MICROSTAAR ® INJECTOR
• Type of Device: INTRAOCULAR LENS GUIDE
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 5971468
• MDR Text Key: 55442691
• Report Number: 2023826-2016-01227
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K940593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL - LOT NUMBER - UNK; MODEL: AQ2010V- SERIAL # (B)(4)
• Patient Age: 68 YR