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

Model Number VTICM5_12.6

Device Problem Misfocusing (1401)

Patient Problem Blurred Vision (2137)

Event Date 01/18/2023

Event Type  Injury  

Manufacturer Narrative

B3 - unk.D6a - unk.D6b - unk.H6- health effect impact code 4625: lasik.H6 - work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).

Event Description

The reporter indicated that a 12.6mm, vticm5_12.6, -10.0/3.0/090 (sphere/cylinder/axis), implantable collamer lens was implanted into the patient's right eye (od).Lens was repositioned on (b)(6) 2023 and (b)(6) 2023, this did not resolve the problem.Lens was exchanged with a spherical lens on (b)(6) 2023 due lsens rotation not associated to a low vault and blurred vision.This resolved the problem.Reportedly, lasik performed to correct the cyl.

• 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
• MDR Report Key: 18835818
• MDR Text Key: 336861210
• Report Number: 2023826-2024-00862
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542115001
• UDI-Public: 00841542115001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2024

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: 04/30/2024
• Device Model Number: VTICM5_12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/30/2022
• 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: INJECTOR MODEL#LIOLI-24,LOT#UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR
• Patient Sex: Male