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

Model Number MSI-PM

Device Problem Delivery System Failure (2905)

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

Event Date 07/20/2015

Event Type  malfunction  

Manufacturer Narrative

The injector was not returned, however , the lens was received and evaluated.There was a tear noted and a piece of the optic was torn off and missing.The was evidence of a clear surgical residue.L.(b)(4).

Event Description

The customer reported the +16.5 diopter aq2010v silicone three piece lens was torn by the injector during insertion.The lens was removed and replaced.No patient injury reported.

Manufacturer Narrative

(b)(4).Evaluation result: upon review of the device history record, there is nothing in the manufacturing, inspection and packaging process records that suggests a contributory factor in the complaint.A work order search was performed and no similar complaints were found.Conclusion: based on the complaint history, work order search, product evaluation, medical review, and device history record review, a specific root cause of the event could not be determined.Claim # (b)(4).

Manufacturer Narrative

Evaluation results: per medical review - reportedly, 3-piece silicone iol was torn during insertion requiring intraoperative lens removal/exchange.Another lens of same model and diopter was successfully implanted.Incision was not enlarged and no other tissue damage was reported.According to the report, by a nurse, dated on (b)(4) 2015, the most likely cause of the event was injector.Conclusion: (unable to confirm complaint); based on the complaint history, product evaluation, and medical review, a specific root cause of the event could not be determined.

• 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: 5053937
• MDR Text Key: 24942683
• Report Number: 2023826-2015-01142
• 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: Followup,Followup
• Report Date: 08/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: MSI-PM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2016
• 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: AQ CARTRIDGE FP MODEL, LOT NUMBER UNKNOWN
• Patient Age: 58 YR