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

Model Number FOAM TIP PLUNGER

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2014

Event Type  malfunction  

Event Description

The customer reported the foam tip plunger was found broken, a little piece detached when the icl was loaded.Surgery was performed without any inconveniences.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Method: device history review.Results: visual inspection of the returned product confirmed that the ftp has a small cut, however, review of the manufacturing process indicates that a defective plunger could not have been released.Based on the information provided, although possible, it is difficult to determine if the cause of the complaint was a user error.Conclusion: based on the complaint information, product evaluation and device history review, we were unable to determine a specific root cause of the event.(b)(4).

• 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: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 4135072
• MDR Text Key: 18541135
• Report Number: 2023826-2014-00767
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K980696
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2016
• Device Model Number: FOAM TIP PLUNGER
• Device Lot Number: 1293797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2013
• 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