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

Model Number MSI-PM

Device Problems Bent (1059); Delivery System Failure (2905)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2016

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer?: no.The product pertaining to this complaint was not returned for evaluation.However, the lens was returned and visual inspection found piece of haptic torn off and missing.The optic is torn at the loop haptic junction.There was evidence of dry clear surgical residue on optic surface.(b)(4).

Event Description

The reporter stated the surgeon implanted an aq2010v +06.00 three piece silicone lens.The lens tore on insertion into the patient's right eye.The lens was removed and another lens, same model and size was implanted.There was no patient injury.Cause of lens tear was a faulty injector.The plunger tip on the injector was bent.No lot number was provided to injector.See mfr.#2023826-2016-0000120 for lens.

Manufacturer Narrative

Method: device history record review result: upon review of the device history record, there is nothing in the manufacturing, inspection and packaging process records to suggest a contributory factor to the complaint.Conclusion: based on the complaint history, work order search, medical review, device history record review and the lens evaluation, a specific root cause of the event could not be determined.Claim # (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: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 5464951
• MDR Text Key: 39206721
• Report Number: 2023826-2016-00212
• 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: Initial,Followup
• Report Date: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: MSI-PM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2016
• Initial Date FDA Received: 02/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/28/2016
• 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
• Patient Age: 71 YR