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

Model Number MSI-PF

Device Problem Ejection Problem (4009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/07/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The reporter indicated that a microstaar injector, intraocular lens folder and injector, failed to inject lens smoothly.Reportedly, "very strong force needed to push plunger.The lens injected vertcally and touched the corneal edothelium.The lens was repositioned.There was no adverse event to the patient.Cause of the event is reported as device.

Manufacturer Narrative

H3.Device evaluation: the cartridge was returned in a plastic bag.Visual inspection found the catridge tip deformed, residue on catridge tip, and catridge tip has a rough edge.H6.Type of investigation 3331 device history record (dhr) review: based on the results of the investigation, all released.Devices from the associated work order(s), including the suspected device, have been manufactured within established process.Parameters and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.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: 10937923
• MDR Text Key: 219369766
• Report Number: 2023826-2020-02773
• 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: 11/10/2020

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: 04/30/2023
• Device Model Number: MSI-PF
• Device Catalogue Number: N/A
• Device Lot Number: 1490026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2020
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/03/2020
• Supplement Dates Manufacturer Received: 12/30/2020
• Supplement Dates FDA Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL#SFC-45,LOT#148859; FOAMTIPPLUNGER MODEL#FTP,LOT#1490709; INJECTOR MODEL#MSI-PF,LOT#1490026; CARTRIDGE MODEL#SFC-45,LOT#148859; FOAMTIPPLUNGER MODEL#FTP,LOT#1490709; INJECTOR MODEL#MSI-PF,LOT#1490026