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

Model Number	MICL 12.6
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No similar complaint type events were reported for units within the same lot.Claim# (b)(4).
Event or Problem Description
He reporter indicated that the surgeon implanted upside down a 12.6mm micl12.6, -16.0 diopter, implantable collamer lens, into the patient's right eye on (b)(6) 2021.There was patient contact (lens touched the eye) with no patient injury.The lens was replaced during initial surgery on (b)(6) 2021.The problem was resolved.Cause of the event is reported as user error,device, "lens came out and slightly turned upside down.Tore lens during hand over hand removal." reportedly, "all ok so far.".
Additional Manufacturer Narrative
H3 - device evaluation: lens was returned in pouch and vial, in liquid.Visual inspection found haptic 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: 11778980
• Report Number: 2023826-2021-01318
• Device Sequence Number: 3894274
• Product Code: MTA
• UDI-Device Identifier: 00841542103145
• UDI-Public: 00841542103145
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: MICL 12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2021
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR