MAUDE Adverse Event Report: STAAR SURGICAL COMPANY MICROSTAAR® INJECTOR; INTRAOCULAR LENS FOLDERS AND INJECTORS

Model Number FOAM TIP PLUNGER

Device Problems Bent (1059); Device Damaged by Another Device (2915); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2016

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer? no - the foam tip plunger, lens and injection system were not returned.(b)(4).Foam tip plunger not returned.

Event Description

The reporter stated the surgeon inserted an 13.2mm micl13.2 implantable collamer lens, -11.5 diopter, on (b)(6) 2016 and the foam tip plunger caught and tore the haptic.The lens was removed within the same surgery, with no patient injury and the backup lens was implanted.The reporter stated the foam tip plunger was bent.The lens was discarded.The patient's post-op best-corrected visual acuity was 20/20+ and the patient is doing great.

• Brand Name: MICROSTAAR® INJECTOR
• Type of Device: INTRAOCULAR LENS FOLDERS AND INJECTORS
• 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: 5965490
• MDR Text Key: 55209088
• Report Number: 2023826-2016-01299
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980696
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2018
• Device Model Number: FOAM TIP PLUNGER
• Device Lot Number: 1342348
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2015
• 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
• Treatment: CARTRIDGE MODEL AND LOT NUMBER UNK; INJECTOR MODEL AND LOT NUMBER UNK; LENS MODEL MICL13.2 - SERIAL NUMBER (B)(4)
• Patient Age: 29 YR