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

Model Number	MICL12.6
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 stated that a 12.6mm,micl12.6, -5.5 diopter, implantable collamer lens tore when implanting into the patients right eye (od).Lens was removed and backup lens was implanted.There was no harm to the patient.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
B5- the reporter indicated that a 12.6mm, micl12.6, -5.5 diopter, implantable collamer lens tore when implanting into the patients right eye (od) on (b)(6) 2021.The lens was removed and replaced within the same surgery and the problem resolved.It was reported that the cause of this event was user error and that the device did not fail to perform as intended.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
• Manufacturer (Section G): STAAR SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 12321643
• Report Number: 2023826-2021-03142
• Device Sequence Number: 16832794
• Product Code: MTA
• UDI-Device Identifier: 00841542103350
• UDI-Public: 00841542103350
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2021

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: 03/31/2022
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL: SFC-45 W/FTP, LOT# 1522240; FTP, LOT # 1522265; INJECTOR MODEL: MSI-PF, LOT# 1493078
• Patient Age: 45 YR
• Patient Sex: Female