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

Model Number MSI-PF

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 07/05/2019

Event Type  malfunction  

Manufacturer Narrative

No patient involvement.The product is manufactured in the us, but not marketed in the us.Injector work order search: no similar complaint type events reported for units within the same lot.(b)(4).

Event Description

The reporter indicated the surgeon states he is unable to push the msi-pf plunger smoothly.The cause of the event is reported as the device.There is no lens or patient associated to this event.

Manufacturer Narrative

Concomitant medical products and therapy dates: date: unk.Device evaluation: injector was returned wrapped in bubble wrap with clear surgical residue.Visual inspection found no visible damage and clear surgical residue on the injector.No cartridge or lens were returned.Claim#: (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
• MDR Report Key: 8870914
• MDR Text Key: 158711495
• Report Number: 2023826-2019-01405
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• PMA/PMN Number: K980696
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 07/11/2019

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: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: MSI-PF
• Device Catalogue Number: N/A
• Device Lot Number: 1428642
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/11/2019
• Initial Date FDA Received: 08/07/2019
• Supplement Dates Manufacturer Received: 08/23/2019
• Supplement Dates FDA Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1