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

Model Number VICMO12.6

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Headache (1880); Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/20/2023

Event Type  Injury  

Event Description

The reporter indicated that a 12.6mm vicmo12.6 implantable collamer lens of -11.0 diopter was implanted into the patient's left eye (os) on (b)(6) 2023.On (b)(6) 2023, the lens was removed.Reportedly, "the patient underwent bilateral icl lens implantation in our hospital on (b)(6) 2023.After the operation, he complained of a headache and discomfort." the problem was resolved.Cause reported as a patient related factor.

Manufacturer Narrative

A4-a6:unk.H6: patient related factor.Claim# (b)(4).

Manufacturer Narrative

H6-health effect- impact code: "1880" and "2330" should be added.D.6a should be corrected to 02/18/2023.B5- the reporter indicated that the surgeon implanted a 12.6mm vicmo 12.6 implantable collamer lens of diopter -11.0 into the patient's left eye (os) on 18/feb/2023.The patient experienced headaches and discomfort.On 04/march/2023 the lens was explanted and the problem was resolved.The reporter indicated the cause of the event was a patient related factor and the device failed to perform as intended.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC 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 enriquez ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 16766108
• MDR Text Key: 313559059
• Report Number: 2023826-2023-01418
• Device Sequence Number: 1
• Product Code: MTA
• 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: 03/04/2023

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: VICMO12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2023
• Initial Date FDA Received: 04/18/2023
• Supplement Dates Manufacturer Received: 06/21/2023
• Supplement Dates FDA Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2022
• 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: UNK.
• Patient Outcome(s): Required Intervention
• Patient Sex: Male