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

Model Number MSI-TR

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/24/2014

Event Type  malfunction  

Event Description

The customer reported the injector pusher tore the aa4203tl silicone single piece lens during advancement into the eye.The lens was removed and discarded.No patient injury was reported.Additional information was requested but not yet forthcoming.If any additional information is obtained a supplemental medwatch form will be submitted.

Manufacturer Narrative

(b)(4).Evaluation conclusion: based on the complaint information, we were unable to determine a specific root cause of the event.(b)(4).

Manufacturer Narrative

Method - (process evaluation): work order search, device history record review.Results - (evaluation result): a lens work order search was performed and no similar complaints were found within the work order.A review of the device history record was performed and nothing was found within the manufacturing process of the lens or the injector that was the root cause of the complaint.Conclusion - (unable to confirm complaint): based on the complaint history, work order search and device history record review, a specific root cause of the event could not be determined.(b)(4).

Manufacturer Narrative

An injector lot search found no similar complaints.Per medical review - reportedly, iol( one-piece silicone) was torn by injector during insertion requiring lens removal.No incision enlargement or other tissue damage was reported.No reported postoperative sequelae.No reported problem with the device (lens and/or injector).It should be noted that user error (during loading or handling) could have caused/contributed to the event.Based on the complaint history, work order search, device history review, injector lot search, and medical review, a specific root cause of the event could not be determined.(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: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 4334143
• MDR Text Key: 5257972
• Report Number: 2023826-2014-01119
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954600
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: MSI-TR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/09/2015
• 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 AA4203TL, SERIAL# (B)(4)
• Patient Age: 60 YR