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 Known Impact Or Consequence To Patient (2692)
Date of Event	07/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight: unk.Ethnicity: unk.Race: unk.Work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).
Event or Problem Description
The reporter indicated that the a 12.6mm micl12.6, -11.5 diopter, implantable colander lens, meant for the patient's eye on (b)(6) 2020 had "a brown spot on the lens.Lens was never inserted, back-up lens implanted.This resolved the problem.Cause of the event is reported as device.Reportedly, patient is "recovering at a normal rate.".
Additional Manufacturer Narrative
Additional information: h3 - device evaluation: lens was returned in vial, in liquid.Visual inspection found no visible damage to lens.Foreign material on lens surface.Lens was observed @ 2x no brown spot was noted.Claim#(b)(4).
Additional Manufacturer Narrative
Corrected data: b4: in initial mdr should be corrected to 24-jul-2020.B5: the statement " backup lens implanted" is not applicable.G4: in initial mdr should be corrected to 24-jul-2020.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
• MDR Report Key: 10404418
• Report Number: 2023826-2020-01706
• Device Sequence Number: 11560876
• Product Code: MTA
• UDI-Device Identifier: 00841542103053
• UDI-Public: 00841542103053
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2020

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: 11/30/2021
• 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: 08/05/2020
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 08/18/2020; 05/27/2021
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 08/20/2020; 06/03/2021
• 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: MSI-PF LOT# 1471029; FOAM TIP PLUNGER LOT# 1471719; INJECTOR MODEL: MSI-PF LOT # 1426559
• Patient Age: 34 YR