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

Model Number	TMICL12.6
Medical Device Problem Codes	Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation type 4110: lens work order search-no similar complaint type events reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that a 12.6mm tmicl12.6 implantable collamer lens, -5.0/+1.0/114 (sphere/cylinder/axis) was implanted into the patient's right (od) eye.Reportedly, it will possibly be explanted.Attempts to obtain additional information have not been successful.
Additional Manufacturer Narrative
B1-updated.B5-additional information: reportedly, the lens was explanted on (b)(6) 2021, due to excessive vault.The status of the eye is myopia and astimatism.The cause of the event is reported as a patient-related factor: "despite accurate wtw measurements and appropriate icl size, excessive vault was present with slit ac depth but normal iop." h6-health impact code: updated.Device code: updated.Device code 1494: off-label use (history of previous corneal or refractive surgery).Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 11197015
• Report Number: 2023826-2021-00181
• Device Sequence Number: 19758135
• Product Code: QCB
• UDI-Device Identifier: 00841542106146
• UDI-Public: 00841542106146
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: 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
• Report Date (Section B): 12/29/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: TMICL12.6
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/29/2020
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 03/02/2021
• 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#-1502316.; FOAM TIP PLUNGER MODEL-FTP, LOT#-1508016.; INJECTOR MODEL-MSI-PF, LOT#-1481823.; UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR