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

Model Number VTICMO13.2

Device Problem Inadequacy of Device Shape and/or Size (1583)

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

Event Date 01/27/2024

Event Type  Injury  

Event Description

The reporter indicated that the surgeon implanted a 13.2mm vticmo13.2; -10.5/2.0/095 (sphere/cylinder/axis) implantable collamer lens into the patient's right eye (od) on (b)(6)2024.The patient experienced excessive vaulting.On this same date in a separate surgery the lens was exchanged with a same length lens but implanted in a different axis.This resolved the problem.The cause of the event was reported as unknown.

Manufacturer Narrative

H6 - type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.Claim# (b)(4).

Manufacturer Narrative

H3: device evaluation: lens was returned in a microcentrifuge vial, dry.Visual inspection found the lens haptic bent/deformed.Dimensional inspection found the lens within specifications.Claim#: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC TORIC INTRAOCULAR LENS
• 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 ave; monrovia, CA 91016
• MDR Report Key: 18827239
• MDR Text Key: 336791501
• Report Number: 2023826-2024-00958
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VTICMO13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2023
• 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#-UNK.; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK.; INJECTOR MODEL-MSI-PF, LOT#-UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR
• Patient Sex: Male