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

Model Number VTICMO12.1

Device Problems Misfocusing (1401); Off-Label Use (1494); Device Dislodged or Dislocated (2923)

Patient Problems Blurred Vision (2137); Swelling/ Edema (4577)

Event Date 04/11/2023

Event Type  Injury  

Event Description

The reporter indicated the surgeon implanted a 12.1mm vticmo12.1 implantable collamer lens, -11.00/+1.0/095 (sphere/cylinder/axis), in the patients right eye (od), on (b)(6) 2023.The lens was explanted on (b)(6) 2023 due to lens rotation not associated to a low vault, eye swelling and blurred vision.The lens was replaced with another same model/length lens (implanted vertically) and the problem was resolved.The cause of the event was unknown.

Manufacturer Narrative

A4: unk, a5: unk, a6: unk.H6 - device code: 1494 - this lens model is contraindicated for patients with an anterior chamber depth (acd) less than 3.0mm.Claim # (b)(4).

Manufacturer Narrative

B5 - it was also reported that the surgeon had repositioned the lens on (b)(6) 2023 before exchanging the lens.H3 - device evaluation - lens was returned in a microcentrifuge vial, dry.Visual inspection found no visble damage to the lens.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 avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 17541754
• MDR Text Key: 321142393
• Report Number: 2023826-2023-03429
• 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,Followup
• Report Date: 07/21/2023

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: VTICMO12.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2023
• Initial Date FDA Received: 08/14/2023
• Supplement Dates Manufacturer Received: 10/25/2023
• Supplement Dates FDA Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2022
• 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 MODEL FTP - LOT # UNK; INJECTOR MODEL MSI-PF - LOT # UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR
• Patient Sex: Female