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

Model Number	MICL 13.2
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Claim #: (b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm, micl13.2, -11.0 diopter, implantable collamer lens tore during loading.There was no patient contact and a backup lens was implanted.Cause of event is unknown.
Additional Manufacturer Narrative
Device evaluation : lens was returned in liquid, inside lens vial.Visual inspection found one of the haptics torn.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 10712186
• Report Number: 2023826-2020-02497
• Device Sequence Number: 3899182
• Product Code: MTA
• UDI-Device Identifier: 00841542103312
• UDI-Public: 00841542103312
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2020

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: 12/31/2021
• Device Model Number: MICL 13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 11/26/2020
• 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# 1492562; INJECTOR MODEL: MICROSTARR, LOT # UNK; CARTRIDGE MODEL: SFC-45 W/FTP, LOT# 1492562; INJECTOR MODEL: MICROSTARR, LOT # UNK