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

Model Number	MICL12.1
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that a 12.1mm, micl12.1, -6.5 diopter, implantable collamer lens was implanted upside down (unfolded upside down) into the patients left eye (os) on (b)(6) 2020.The lens was removed and replaced with the backup lens within the same surgery with no patient injury.Problem resolved, no issues, vision doing well.
Additional Manufacturer Narrative
Additional information: h3- device evaluation: lens was returned in liquid in a lens vial.Visual inspection found the 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
• MDR Report Key: 10125666
• Report Number: 2023826-2020-01216
• Device Sequence Number: 2925283
• Product Code: MTA
• UDI-Device Identifier: 00841542104548
• UDI-Public: 00841542104548
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2020

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: 12/31/2020
• Device Model Number: MICL12.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2020
• Initial Date Received by Manufacturer: 05/08/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL: SFC-45 W/FTP, LOT# UNK; INJECTOR MODEL: MSI-PF, LOT# 1442890
• Patient Age: 30 YR