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

Device Problems Break (1069); Device Operates Differently Than Expected (2913); Torn Material (3024)

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

Event Date 09/30/2016

Event Type  Injury  

Event Description

The reporter indicated the surgeon attempted to insert a 12.6mm vticmo12.6 implantable collamer lens, -6.5/+4.0/157 diopter, on (b)(6) 2016, and the injector system broke.The lens was torn and the surgery could not be completed.The lens was not implanted.Another same model/length lens was implanted on (b)(6) 2016 and the problem was resolved.

Manufacturer Narrative

(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: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 6108234
• MDR Text Key: 60070543
• Report Number: 2023826-2016-01648
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K980696
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2017
• 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: LENS MODEL VTICMO12.6 - SERIAL # (B)(4)
• Patient Age: 32 YR