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

Model Number MICL 13.2

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/23/2021

Event Type  Injury  

Event Description

The reporter indicated that a 13.2mm micl 13.2 implantable collar lens of -13.5 diopter was implanted into the patients left eye (os) on (b)(6) 2021.On (b)(6) 2021 the lens was removed.On the same day different surgery a replacement lens of shorter length was implanted due to excessive vault.This resolved the problem.Cause is reported as device.

Manufacturer Narrative

Weight: unk.Ethnicity: unk.Race: unk.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: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 13123114
• MDR Text Key: 284123174
• Report Number: 2023826-2021-05022
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542103367
• UDI-Public: 00841542103367
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/03/2021

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: 09/30/2022
• Device Model Number: MICL 13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/30/2021
• Date Device Manufactured: 10/22/2020
• 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: CARTRIDGE MODEL: SFC-45: LOT# 1518549; FOAM TIP PLUNGER (FTP), LOT# 1527566; INJECTOR MODEL: MSI-PF, LOT# UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female