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

Model Number MICL13.2

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

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

Event Date 10/07/2021

Event Type  Injury  

Manufacturer Narrative

Age, sex, weight, ethnicity, race - unk.Implant, explant dates - unk.(b)(4).Claim# (b)(4).

Event Description

The reporter states a 13.2mm micl13.2 implantable collamer lens -12.0 diopter was implanted into the patient's eye.Reportedly on the lens was explanted due to it being flipped in the eye.Attempts to obtain additional information have not been successful.

Manufacturer Narrative

B5: additional information: the lens implanted into the patient's right (od) eye on (b)(6) 2021.On the same date in a separate surgery the lens was explanted due to the lens being implanted upside down.The lens was then replaced with an alternate lens and the problem was resolved.No patient injury reported.The cause of the event is reported as user error-the device did not fail to perform as expected.Reportedly, after replacement lens was implanted, "vision and comfort improved-gritty sandy feeling relieved with ats q1hr." claim#: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• Type of Device: PHAKIC 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: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 12755766
• MDR Text Key: 280466445
• Report Number: 2023826-2021-04201
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542103336
• UDI-Public: 00841542103336
• 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,Followup
• Report Date: 10/11/2021

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: 04/30/2023
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 11/06/2021
• Supplement Dates Manufacturer Received: 11/15/2021
• Supplement Dates FDA Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/28/2021
• 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#-UNK.; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK.; INJECTOR MODEL-MSI-PF, LOT#-UNK.; UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female