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

Model Number SFC-45

Device Problems Off-Label Use (1494); No Apparent Adverse Event (3189)

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

Event Date 08/13/2023

Event Type  malfunction  

Event Description

The reporter indicated that a sfc-45 cartridge of unknown lot number head was found cracked after operation.Possible that the cartridge caused a 13.2mm vticmo 13.2 implantable collamer lens of -10-50/2.0/091 (sphere/cylinder/axis) lens tear/break during injection/delivery into the left eye (os) on (b)(6) 2023.The lens was implanted and removed intra-operatively.A replacement lens was later implanted and problem resolved.

Manufacturer Narrative

Claim# (b)(4).

Manufacturer Narrative

A2 - dob (b)(6) 2000 corrected to (b)(6) 2005.H6 - medical device problem code 1494: off-label use (under 21 yrs of age at date of implantation) added to initial mdr.Claim #(b)(4).

• Brand Name: MICROSTAAR INJECTOR
• Type of Device: INTRAOCULAR LENS FOLDERS AND INJECTORS, PRODUCT CODE: MSS
• 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: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 17917066
• MDR Text Key: 325718722
• Report Number: 2023826-2023-04361
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K152357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/11/2023

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 Model Number: SFC-45
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 10/11/2023
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FOAM TIP PLUNGER MODEL FTP - LOT # UNK; INJECTOR MODEL MSI-PF - LOT # UNK; LENS MODEL VTICMO_13.2, SERIAL # (B)(6)
• Patient Age: 18 YR
• Patient Sex: Male