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

Model Number VTICMO13.7

Device Problem Misfocusing (1401)

Patient Problem Blurred Vision (2137)

Event Date 12/03/2023

Event Type  Injury  

Manufacturer Narrative

H6-investigation type 4110: lens work order search- no similar complaint event(s) within associated lots were found.Claim# (b)(4).

Event Description

The reporter indicated that a 13.7mm vticmo implantable collamer lens of -8.5/2.5/006 (sphere/cylinder/axis) was implanted into the patient's left eye (os) on (b)(6) 2023.Refractive surprise was observed.On (b)(6) 2023 the lens was exchanged for a same model and size lens with different power and the problem was resolved.Cause 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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 18772511
• MDR Text Key: 336146184
• Report Number: 2023826-2024-00804
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/25/2024

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: VTICMO13.7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/22/2022
• 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 (FTP), LOT# UNK; INJECTOR MODEL: MSI-PF, LOT# UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male