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

Model Number VTICM5_13.2

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)

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

Event Type  Injury  

Manufacturer Narrative

Pt info: unk.Event date: unk.Work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).

Event Description

The reporter indicated the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens, -09.50/+6.0/133 (sphere/cylinder/axis), into the patients right eye (od) on (b)(6) 2022.The lens was explanted on (b)(6) 2022 due to low vaulting and lens rotation.The lens was replaced with a longer lens.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

H3: device evaluation: the lens was returned in a microcentrifuge vial, with moisture and residue on product.Visual inspection found no visible damage to the lens and residue on the footplate and haptic.Dimensional verification was performed and the lens was found to be in specification.Claim # (b)(4).

Manufacturer Narrative

Corrected data: b5: the reporter indicated the surgeon implanted a 13.2mm vticm5 13.2 implantable collamer lens of diopter -9.5/+6.0/133 (sphere/cylinder/axis) into the patient's eye (od) on (b)(6) 2022.The patient experienced a low vault with rotation.On (b)(6) 2022 the lens exchanged the lens with the same model; similar power and longer length.The cause of the event was a patient related event and the device failed to perform as intended.Reportedly "toric icl rotated due to undersizing".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 enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 15635994
• MDR Text Key: 302057474
• Report Number: 2023826-2022-03706
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: VTICM5_13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2022
• Initial Date FDA Received: 10/19/2022
• Supplement Dates Manufacturer Received: 02/13/2023; 03/28/2023
• Supplement Dates FDA Received: 02/28/2023; 03/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2020
• 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