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

Model Number MSI-TM

Device Problem Delivery System Failure (2905)

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

Event Date 05/06/2015

Event Type  malfunction  

Event Description

The customer reported that the injector was extremely difficult to twist, resulting in tearing the -1.0 diopter aq5010v silicone three piece lens during loading.There was no patient contact.Reporter stated the event was the due to the faulty injector.

Manufacturer Narrative

(b)(4).Visual inspection of the returned product showed evidence of clear surgical residue, however, there was no visible damage to the lens.Additionally, 3 injector were returned and 2 of them were difficult to twist.Based on the complaint history and evaluation of the returned product, a specific root cause of the event could not be determined.A capa has been opened to investigate issues involving the msi injectors.Once the capa is closed, a supplemental medwatch will be submitted.(b)(4).

Manufacturer Narrative

Event problem and evaluation codes: method: (process evaluation): device history record review, lens work order search.Results: (evaluation result): a review of the device history record was performed and nothing was found in the manufacturing, inspection and packaging process records that suggests a contributory factor in the complaint.A lens work order search was performed and no similar complaints were found within the work order.Conclusion: (unable to confirm complaint): based on the complaint history, lens work order search, device history record review and evaluation of the returned product, a specific root cause of the event could not be determined.(b)(4).

• Brand Name: MICROSTAAR® INJECTOR
• Type of Device: INTRAOCULAR LENS GUID
• 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: 4900198
• MDR Text Key: 6022747
• Report Number: 2023826-2015-00772
• 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,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2017
• Device Model Number: MSI-TM
• Device Lot Number: 1308893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/28/2016
• Date Device Manufactured: 06/19/2014
• 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, LOT NUMBER UNKNOWN
• Patient Age: 74 YR