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

Model Number	MICL 13.2
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2020
Type of Reportable Event	Serious Injury
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 a 13.2mm, micl13.2, -11.50 diopter, implantable collamer lens was implanted into the patients left eye (os) on (b)(6) 2020.On (b)(6) 2020 the lens was explanted due to lens rotation not associated to a low vault.This explant resolved the problem, patient is happy in glasses.Will return to contact lenses.In the reporter opinion the cause of this event was the device, reporter stated " icl was well aligned & well vaulted pod #1 significant rotation of around 40 degrees.Normal vault ".

• 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: 10988498
• Report Number: 2023826-2020-02952
• Device Sequence Number: 3548360
• Product Code: MTA
• UDI-Device Identifier: 00841542103329
• UDI-Public: 00841542103329
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2000

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: MICL 13.2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL: SFC-45 W/FTP, LOT# 1460486; FOAM TIP PLUNGER, LOT # 1456863
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR