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

Model Number VTICM5_13.2

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Headache (1880); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2022

Event Type  Injury  

Manufacturer Narrative

Patient identifier: unk.Procode: 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, -09.00/+3.5/092 (sphere/cylinder/axis), in the patients left eye (os), on aug-2022.The lens was reported as excessive vaulting and remained implanted.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

B5: the lens was explanted on (b)(6) 2023 due to excessive vaulting.The patient also complained of pain and pressure sensation in the eye, so the lens was removed.Post-op, the patient has been seeing the surgeon every 2 weeks, sometimes complaining of pain in the eye, sometimes of pressure and headaches.She has already visited the emergency room several times (without results).H6: health impact- clinical code: 4581 - pressure sensation.Claim # (b)(4).

Manufacturer Narrative

Claim# (b)(4).

Manufacturer Narrative

H3 - type of investigation code: 10- device evaluation: the lens was returned in a microcentrifuge vial with moisture.Visual inspection found no visible damage.Dimensional inspection found the lens to be 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 enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 16275294
• MDR Text Key: 308537582
• Report Number: 2023826-2023-00263
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup
• Report Date: 01/11/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: VTICM5_13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2023
• Initial Date FDA Received: 01/31/2023
• Supplement Dates Manufacturer Received: 02/03/2023; 05/10/2023; 06/16/2023
• Supplement Dates FDA Received: 04/28/2023; 05/10/2023; 06/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2022
• 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 Age: 24 YR
• Patient Sex: Female