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

Model Number VTICMO13.2

Device Problem No Apparent Adverse Event (3189)

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

Event Date 10/30/2023

Event Type  malfunction  

Manufacturer Narrative

A2: unk.A4: unk.A5: unk.A6: unk.D4: expiration date unk.H4: unk.H6 - work order search: a work order search was performed for the lens and no similar complaint was reported for units within the same lot.Claim (b)(4).

Event Description

The reporter indicated the surgeon implanted a 13.2mm vticmo13.2 implantable collamer lens, -18.00/+1.5/055 (sphere/cylinder/axis) in the patients left eye (os) on 30-oct-2023.The lens was damaged (cracked) during loading due to the sfc45 cartridge, when bringing the lens to the narrow part of the cartridge, and releasing the clamp, the lens would go backwards by itself.After pushing the lens several times with the foam tip from behind to put it back in the narrow part of the cartridge, the lens was implanted and the surgery went well.The lens remained implanted.

Manufacturer Narrative

Model #: vticmo13.2.Manufacture date: 14-sept-2023.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
• 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: 18196843
• MDR Text Key: 328982649
• Report Number: 2023826-2023-05237
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K152357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/03/2023

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: VTICMO13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: 02/26/2024
• Supplement Dates FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/14/2023
• 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: FOAM TIP PLUNGER MODEL FTP - LOT # UNK; INJECTOR MODEL MSI-PF - LOT # UNK; LENS MODEL VTICMO13.2 - SERIAL # (B)(6).
• Patient Sex: Female