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

Model Number ICM12.0

Device Problems Misfocusing (1401); Off-Label Use (1494)

Patient Problem Blurred Vision (2137)

Event Date 11/25/2022

Event Type  malfunction  

Manufacturer Narrative

Work order search found no similar complaints within associated lots were found.Claim# (b)(4).

Event Description

The reporter indicated that a 12.0mm icm12.0 implantable collamer lens of -12.5 diopter was implanted into the patient's right eye (od) on 15-feb-2013.Refractive change overtime was observed.

Manufacturer Narrative

Corrected data: b1: adverse event should be corrected to product problem.B2: outcomes attributed to adverse event- should be omitted for correction.H4: device manufacture date: 23-oct-2012.H6: 1494- off-label: age<21 years old.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 ; 8002927902
• MDR Report Key: 16075853
• MDR Text Key: 306894614
• Report Number: 2023826-2022-04748
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 12/01/2022

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: 09/30/2015
• Device Model Number: ICM12.0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 02/28/2023
• Supplement Dates FDA Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/12/2023
• 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: 29 YR
• Patient Sex: Female