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

Model Number VTICMO13.2

Device Problem Optical Problem (3001)

Patient Problem Halo (2227)

Event Date 01/18/2024

Event Type  Injury  

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).

Event Description

The reporter indicated that the surgeon implanted a 13.2mm vticmo13.2; -16.5/2.5/084 (sphere/cylinder/axis) implantable collamer lens into the patient's left eye (os) on (b)(6)2023.The patient experienced glare/haloes.On (b)(6) 2024 the lens was explanted per the patients request and the problem was resolved.The cause of the event was reported as unknown.

• 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: 18602499
• MDR Text Key: 334025593
• Report Number: 2023826-2024-00478
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00840311327836
• UDI-Public: 00840311327836
• 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
• Report Date: 01/26/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2024
• Initial Date FDA Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2023
• 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: 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: 30 YR
• Patient Sex: Female