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

Model Number VICM5_12.1

Device Problem Optical Problem (3001)

Patient Problems Blurred Vision (2137); Visual Disturbances (2140); Halo (2227); Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/16/2022

Event Type  Injury  

Manufacturer Narrative

Claim# (b)(4).

Event Description

The reporter indicated that a 12.1mm vicm5_12.1 implantable collamer lens -11.50 diopter was implanted into the patient's right eye (od) on (b)(6) 2022.The patient experienced glare/haloes and discomfort due to over correction.On (b)(6) 2022 the lens was exchanged for a different diopter lens and the problem resolved.

Manufacturer Narrative

Corrected data: h6- health effect- clinical code: 4581- over correction.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
• MDR Report Key: 16329543
• MDR Text Key: 309123254
• Report Number: 2023826-2023-00464
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 01/09/2023

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: VICM5_12.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2023
• Initial Date FDA Received: 02/08/2023
• Supplement Dates Manufacturer Received: 04/17/2023
• Supplement Dates FDA Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/12/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female