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

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 12/20/2021

Event Type  malfunction  

Manufacturer Narrative

Weight: unk.Race: unk.Ethnicity: unk.(b)(4).Claim # (b)(4).

Event Description

The reporter indicated the surgeon was loading a 12.6mm vticm5_12.6 implantable collamer lens, -13.50/+2.0/090 (sphere/cylinder/axis), and the lens tore.There was no patient contact.The lens was replaced with another same model/length lens and the problem was resolved.The surgeon indicated the cause was unknown but felt some resistance with the cartridge.It seemed the nozzle of the cartridge was narrower than usual.

Manufacturer Narrative

Weight: unk.Race: unk.Ethnicity: unk.(b)(4).Claim # (b)(4).

Event Description

The reporter indicated the surgeon was loading a 12.6mm vticm5_12.6 implantable collamer lens, -13.50/+2.0/090 (sphere/cylinder/axis), and the lens tore.There was no patient contact.The lens was replaced with another same model/length lens and the problem was resolved.The surgeon indicated the cause was unknown but felt some resistance with the cartridge.It seemed the nozzle of the cartridge was narrower than usual.

Manufacturer Narrative

H6: 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).

Manufacturer Narrative

H3: device evaluation: the cartridge was returned in the device tray.Visual inspection found the cartridge tip split.H6 - cartridge lot number search: no similar complaint was reported for units within the same lot.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: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 13447236
• MDR Text Key: 285961025
• Report Number: 2023826-2022-00294
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 01/07/2022

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: SFC-45
• Device Lot Number: 1542791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2022
• Initial Date FDA Received: 02/03/2022
• Supplement Dates Manufacturer Received: 02/14/2022; 03/17/2022
• Supplement Dates FDA Received: 03/08/2022; 03/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2021
• 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 # 1545968; INJECTOR MODEL MSI-PF - LOT # UNK; LENS MODEL VTICM5_12.6, SERIAL # (B)(4).
• Patient Age: 19 YR
• Patient Sex: Female