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

Model Number AQ CARTRIDGE-FP

Device Problem Delivery System Failure (2905)

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

Event Date 06/15/2015

Event Type  malfunction  

Event Description

The customer reported the surgeon could not get the +22.0 diopter aq2010v silicone three piece lens to advance in the cartridge.There was no patient contact.The reporter stated the surgeon indicated the cartridge was too tight.

Manufacturer Narrative

(b)(4).Conclusion: based on the complaint information, we were unable to confirm this report.The product has yet to been returned.(b)(4).

Manufacturer Narrative

The cartridge was not returned, however, the lens was received with a clear surgical residue and there was no visible damage observed.(b)(4).

Manufacturer Narrative

A review of the device history record was performed and nothing was found in the manufacturing process of the cartridge that was the root cause of the complaint.A lens work order search was performed and no similar complaints were found.A cartridge lot search found (b)(4) similar complaints.Based on the complaint history, work order search, device history record review, cartridge lot search and the evaluation of the returned lens, 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: 4936201
• MDR Text Key: 6016302
• Report Number: 2023826-2015-00918
• 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
• Type of Report: Initial,Followup
• Report Date: 07/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: AQ CARTRIDGE-FP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2015
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 67 YR