MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC INTRAOCULAR LENS

Model Number VICM512.6

Device Problems Improper or Incorrect Procedure or Method (2017); No Apparent Adverse Event (3189)

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

Event Date 05/19/2023

Event Type  malfunction  

Event Description

The reporter indicated that on a 12.6mm vicm512.6 implantable collamer lens of a -8.5 diopter tore during loading.Reportedly, "product non-conformity.Backup lens was used due to lens tear during loading." the problem was resolved.Cause of the event was both unknown and a user error.The reporter also stated, "when pulling the lens into the cartridge with forcep, it felt tighter tha usaul, but i just pulled it in.".

Manufacturer Narrative

A4-a6:unk.H6: off-label.Claim# (b)(4).

Manufacturer Narrative

Corrected data: b5- \the reporter indicated that the surgeon noted a 12.6mm vicm5_12.6 implantable collamer lens of diopter -8.50 tore/broke before/during loading on (b)(6) 2023.The damage occurred during loading.Reportedly "product non conformity (no patient involvement)- "backup lens was used due to lens tear during loading".The lens was not implanted.On the same day a backup lens of the same parameters was implanted into the left eye (os) and the problem was resolved.The cause of the event is user error/ unknown.Cause details: "when pulling the lens into the cartridge with forcep, it felt tighter than usual, but i just pulled it in." h6- health effect - impact code: "4629" should be removed and "2645" should be added.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SUGICAL COMPANY; 1911 walker avenue; monrovia 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 17253294
• MDR Text Key: 318507648
• Report Number: 2023826-2023-02660
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030016
• 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: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VICM512.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2023
• 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: CARTRIDGE MODEL: SFC-45 - LOT# 1583691; FOAM TIP PLUNGER - LOT# UNK; INJECTOR MODEL: MSI-PF - LOT# 1572655
• Patient Age: 44 YR
• Patient Sex: Male