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

Model Number	MICL12.6
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lens work order search-no similar complaint type events reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated a 12.6mm micl12.6 implantable collamer lens, -7.5 diopter flipped during implant into the eye.On (b)(6) 2021 the lens was explanted.Attempts to obtain additional information have not been successful.
Additional Manufacturer Narrative
H3-device evaluation: the lens was returned in liquid in a micro-centrifuge vial.There was residue on the lens surface.Visual inspection found that the haptic was torn.(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 11340678
• Report Number: 2023826-2021-00382
• Device Sequence Number: 934007
• Product Code: MTA
• UDI-Device Identifier: 00841542102971
• UDI-Public: 00841542102971
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021

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: 09/30/2022
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention