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

Model Number VTICMO12.6

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Eye Pain (4467); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/31/2023

Event Type  Injury  

Event Description

The reporter indicated the surgeon implanted a 12.6mm vticmo12.6 implantable collamer lens, -15.50/+1.5/067 (sphere/cylinder/axis), in the patients left eye (os), on (b)(6) 2023.The lens was explanted on (b)(6) 2023 due to patient was experiencing orbital pain due to psychological effects and the problem was resolved.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

H6 - device code: 1494 - this lens model is contraindicated for patients with an anterior chamber depth (acd) less than 3.0mm.H6 - work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).

Manufacturer Narrative

Corrected data: b5: the reporter indicated the surgeon implanted a 12.6mm vticmo12.6 implantable collamer lens, -15.50/+1.5/067 (sphere/cylinder/axis), into the patients left eye (os) on (b)(6)2023.The lens was explanted on (b)(6) 2023 due to the patient had a sense of shaking and could not adapt himself, so he requested the icl be removed.The surgeon felt that it may be related to the abnormal adjustment function of the patient.The patient would not cooperated with the later examination and treatment.The problem was resolved.H6: health effect: clinical code (e): 4582 (patient did not have any pain).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: 18389058
• MDR Text Key: 331265516
• Report Number: 2023826-2023-05729
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00840311322770
• UDI-Public: 00840311322770
• 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: 12/11/2023

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: VTICMO12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 02/19/2024
• Supplement Dates FDA Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/13/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Sex: Male