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

Model Number	MICL13.2
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sex, weight, ethnicity, race: unk.Date of event : unk.Implant date, explant date: unk.(b)(4): lens work order search-no similar complaint type events reported for units within the same lot.Claim# (b)(4).
Event or Problem Description
The reporter states a 13.2mm micl13.2 implantable collamer lens -6.0 diopter was "vold to flat, remove." attempts to obtain additional information have not been successful.
Additional Manufacturer Narrative
On (b)(6) 2021 a 13.2mm micl13.2, -6.0 diopter implantable collamer lens was implanted in the patient's left (os) eye.On (b)(6) 2021, the lens was explanted due to low vault.The cause of the event is reported as device.H3-device evaluation: the lens was returned in liquid in a vial.Visual inspection found that the haptic was torn.Claim# (b)(4).
Additional Manufacturer Narrative
(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 11823295
• Report Number: 2023826-2021-01444
• Device Sequence Number: 3721923
• Product Code: MTA
• UDI-Device Identifier: 00841542103213
• UDI-Public: 00841542103213
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2021

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: 12/31/2021
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 05/25/2021; 06/21/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 06/17/2021; 07/15/2021
• 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#-1502315.; FOAM TIP PLUNGER MODEL-FTP, LOT#-1509330.; INJECTOR MODEL-MSI-PF, LOT#-UNK.; UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR