MAUDE Adverse Event Report: STAAR SURGICAL COMPANY MICROSTAAR® INJECTOR; INTRAOCULAR LENS FOLDERS AND INJECTORS

Model Number SFC-45

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

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 no visible damage to the lens.(b)(4).Device not returned.

Event Description

The reporter stated the surgeon tried to inject a 12.6mm micl12.6 implantable collamer lens, -14.5 diopter, and the lens would not come out from the cartridge.There was a patient contact with the cartridge but not with the lens.The reporter stated the cause of the event was due to the cartridge.There was no patient injury and the backup lens was implanted.

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 of the returned product found no visible damage to the lens.The lens was returned in vial in liquid.(b)(4).

• Brand Name: MICROSTAAR® INJECTOR
• Type of Device: INTRAOCULAR LENS FOLDERS AND INJECTORS
• 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: 5807446
• MDR Text Key: 49946695
• Report Number: 2023826-2016-00963
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980696
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: SFC-45
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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