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

Model Number VTICM512.6

Device Problems Off-Label Use (1494); Optical Problem (3001)

Patient Problems Halo (2227); Discomfort (2330)

Event Date 03/17/2023

Event Type  Injury  

Manufacturer Narrative

H6: work order search: no similar complaints from associated lots were found.Claim# (b)(4).

Event Description

The reporter indicated that a 12.6mm vticm512.6 implantable collamer lens of 13.5/3.0/91 (sphere/cylinder/axis) was implanted into the patients right eye (od) on (b)(6) 2023.On (b)(6) 2023 the lens was removed due to patient discomfort/glare and haloes.The problem was resolved.

Manufacturer Narrative

Corrected data: h6- health effect- clinical code: "2330" should be added.H6- medical device code: 1494- off label use (age<21).B5- the reporter indicated that the surgeon implanted a 12.6mm vticm5_12.6mplantable collamer lens of diopter -13.5/+3.0/091 (sphere/cylinder/axis) into the patient's right eye (od) on (b)(6) 2023.The patient experienced discomfort and glares/haloes.On (b)(6) 2023 the lens was explanted and the problem was resolved.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 muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 17051835
• MDR Text Key: 316466523
• Report Number: 2023826-2023-02126
• Device Sequence Number: 1
• Product Code: QCB
• 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: 05/11/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: VTICM512.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2023
• Initial Date FDA Received: 06/02/2023
• Supplement Dates Manufacturer Received: 07/19/2023
• Supplement Dates FDA Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/12/2022
• 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
• Treatment: UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR
• Patient Sex: Male