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

Model Number	MICL13.2
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age, sex, weight, ethnicity, race - unk.Implant, explant dates - unk.(b)(4).Claim# (b)(4).
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2023826-2021-04201
• Device Sequence Number: 4254311
• Product Code: MTA
• UDI-Device Identifier: 00841542103336
• UDI-Public: 00841542103336
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 11/06/2021
• Supplement Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL-SFC-45, LOT#-UNK.; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK.; INJECTOR MODEL-MSI-PF, LOT#-UNK.; UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female