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

Model Number SFC45

Device Problem No Apparent Adverse Event (3189)

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

Event Date 01/18/2024

Event Type  malfunction  

Manufacturer Narrative

A3: unk a4: unk a5: unk.A6: 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 # 733648.

Event Description

The reporter indicated a 12.6mm vticm5_12.6 implantable collamer lens, -11.50/+1.0/093 (sphere/cylinder/axis), was damaged during loading due to the sfc-45 cartridge.When pulling the lens into the tip of cartridge nozzle, the lens slipped inside the nozzle, resulting in repeated pulling, and the lens was damaged.There was no patient contact.The lens was replaced with another same model, length lens and the problem was resolved.

Manufacturer Narrative

H3: device evaluation: the cartridge was returned loose in a plastic bag, with clear surgical residue on product.Visual inspection found no visible damage to the device.There was residue in the cartridge.Claim # (b)(4).

Manufacturer Narrative

H6 - cartridge lot number search: another similar complaint was reported for units within the same lot.H6: device history record (dhr) review: the dhr review indicated that the product has been manufactured within the established process parameters and that there is no indication that the manufacturing and/or 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
• 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: 18725063
• MDR Text Key: 336456938
• Report Number: 2023826-2024-00656
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 01/22/2024

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: SFC45
• Device Lot Number: 1660109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/16/2024
• Supplement Dates Manufacturer Received: 02/28/2024; 03/13/2024
• Supplement Dates FDA Received: 03/08/2024; 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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 # 1654338; INJECTOR MODEL MSI-PF - LOT # UNK; LENS MODEL VTICM5_12.6 - SERIAL # T1486976
• Patient Age: 31 YR