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

Model Number MSI-TM

Device Problems Delivery System Failure (2905); Torn Material (3024)

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

Event Date 04/01/2015

Event Type  malfunction  

Event Description

The customer the surgeon inserted the +12.5 dioper aq2010v three piece silicone lens and doctor saw a scratch or line on the lens.The lens was removed and another lens was implanted without any injury to the patient.The surgeon stated the injector possibly damaged the lens.

Manufacturer Narrative

Pt age and weight: unknown.Expiration date - unknown.Implant and explant dates: n/a.(b)(4).Mfg date: unknown.Conclusion: (unable to confirm): based on the complaint information, we were unable to confirm this complaint.The product has not yet been received.(b)(4).

Manufacturer Narrative

The injector was not returned, however, the lens was received and evaluated.The lens was received in three pieces and a piece of the optic was torn off and missing.There was a dried surgical residue on the surface of the lens.Conclusion: based on the complaint information and evaluation of the returned product, we were unable to confirm this complaint.(b)(4).

Manufacturer Narrative

Per medical review - reportedly, intraoperative lens exchange was performed to address lens defect ("line or scratch") upon insertion.Incision was not enlarged and no other tissue damage was reported.Another lens of same model and diopter was successfully implanted.According to the report by a surgical technician, dated on (b)(6) 2015, the surgeon indicated that the most likely cause of the event was injector.Based on the complaint history, product evaluation, and medical review, a specific root cause of the event could not be determined.(b)(4).

Manufacturer Narrative

Event problem and evaluation codes: method: device history record review.Results: 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.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.(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: 4754500
• MDR Text Key: 17296041
• Report Number: 2023826-2015-00524
• 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,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: MSI-TM
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: No
• 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; LENS MODEL AQ2010V, SERIAL# (B)(4)