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

Model Number	MICL 12.6
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2021
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 on (b)(6) 2021 a micl 12.6, -11.0 diopter, implantable collamer lens tore before/during loading.Damage was noted while loading.A backup lens was implanted and this resolved the problem.Cause of the event is reported as unknown.Per the reporter on (b)(6) 2021, "patient is doing fine.".
Additional Manufacturer Narrative
Additional information: h3 - device evaluation: lens was returned in micro-centrifuge vial, in liquid.Visual inspection found haptic torn.Claim# (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: 11343199
• Report Number: 2023826-2021-00404
• Device Sequence Number: 4959602
• Product Code: MTA
• UDI-Device Identifier: 00841542103046
• UDI-Public: 00841542103046
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2021

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: 09/30/2022
• 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: 02/04/2021
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 03/18/2021
• 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, LOT#1497082; FOAMTIPPLUNGER MODEL#FTP, LOT#1508018; INJECTOR MODEL#MSI-PF, LOT#1422663; CARTRIDGE MODEL#SFC-45, LOT#1497082; FOAMTIPPLUNGER MODEL#FTP, LOT#1508018; INJECTOR MODEL#MSI-PF, LOT#1422663
• Patient Age: 53 YR