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

Model Number	MICL13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter states a 13.2mm micl13.2 implantable collamer lens -9.5 diopter was implanted into the patient's eye.Reportedly the lens was too large and was explanted and replaced with a shorter length lens.No patient injury or sutures reported.Attempts to obtain additional information have not been successful.
Additional Manufacturer Narrative
H3 - device evaluation: the lens was returned in a specimen cup.Visual inspection found the optic torn with residue throughout the lens.Claim # (b)(4).
Additional Manufacturer Narrative
H3 - device evaluation: the lens was returned in a specimen cup.Visual inspection found the optic torn with residue throughout the lens.Dimensional inspection found the lens to be within specifications.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: 12724196
• Report Number: 2023826-2021-04152
• Device Sequence Number: 17169648
• Product Code: MTA
• UDI-Device Identifier: 00841542103282
• UDI-Public: 00841542103282
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 10/05/2021

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: 07/31/2023
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 12/21/2021; 02/04/2022
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 01/19/2022; 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2021
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown