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

Model Number FOAM TIP PLUNGER (FTP)

Device Problem Mechanical Problem (1384)

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

Event Date 09/14/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The reporter indicated that the foam tip plunger got stuck to trailing haptic of icl and in attempts to manually de-attach the icl from sponge head the icl tore.A replacement lens was successfully implanted and the problem was resolved.If additional information is received a supplemental medwatch report will be submitted.

• 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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 17936720
• MDR Text Key: 325843185
• Report Number: 2023826-2023-04370
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K980696
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/14/2023

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 Model Number: FOAM TIP PLUNGER (FTP)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2023
• Initial Date FDA Received: 10/14/2023
• 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
• Treatment: CARTRIDGE MODEL: SFC-45: LOT# UNK; INJECTOR MODEL: MSI-TF, LOT# UNK; LENS MODEL VTICM5_13.2, B)(6)
• Patient Sex: Female