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

Model Number VTICMO13.2

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2022

Event Type  malfunction  

Event Description

The reporter indicated that a 13.2mm vticmo13.2 implantable collamer lens of -9.0/2.0/082 (sphere/cylinder/axis) was implanted into the patient's left eye (os) on (b)(6) 2022.The lens was intraoperatively implanted, removed, and replaced for a smaller length lens due to a lens tear during injection/delivery into the eye.The problem was resolved.Cause of the event is unknown.Status of the eye is reported as, "good.".

Manufacturer Narrative

Weight and age:unk.Work order search: no similar complaints within associated lots were found.Claim# (b)(4).

Manufacturer Narrative

Corrected data: b5: the reporter indicated that the surgeon implanted a 13.2mm vticmo13.2 implantable collamer lens of diopter -9.00/2.0/082 (sphere/cylinder/axis) into the patient's left eye (os) on (b)(6) 2022 when the lens tore/broke during injection/delivery.There was no patient injury.The lens was intraoperatively implanted, removed, and replaced for the same model and power but shorter length and the problem was resolved.The status of the eye was reported as "good".The reporter indicated the cause of the event was a patient related factor and the device failed to perform as intended.H6: medical device problem code 1494: off-label use (under 21 yrs of age at date of implantation).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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 15927338
• MDR Text Key: 308097587
• Report Number: 2023826-2022-04443
• 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: 11/10/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: VTICMO13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2022
• Initial Date FDA Received: 12/06/2022
• Supplement Dates Manufacturer Received: 01/25/2023
• Supplement Dates FDA Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2022
• 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# 1607023.; FOAM TIP PLUNGER - LOT# 1595397.; INJECTION MODEL: MSI-PF - LOT# 1536766.
• Patient Outcome(s): Required Intervention
• Patient Age: 18 YR
• Patient Sex: Female