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

Model Number	TMICL13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pt info: 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 indicated that the surgeon implanted a 13.2mm tmicl13.2 implantable collamer lens -16.0/+1.0/029 (sphere/cylinder/axis) into the patient's right (od) eye on (b)(6) 2021.On (b)(6) 2021 the lens was explanted due to excessive vault, angle closure, and elevated iop.The cause of the event is reported as device: "device being too large caused anterior vault, resulting in narrowing anterior chamber and increased iop.The problem is resolved with the explant.
Additional Manufacturer Narrative
Per email on (b)(6) 2021, the reporter stated that "replacement lens were implanted on (b)(6) 2021.Right eye: (b)(6) & left eye: (b)(6).All problems have been resolved at this time." 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: 12178448
• Report Number: 2023826-2021-02701
• Device Sequence Number: 1493218
• Product Code: QCB
• UDI-Device Identifier: 00841542109857
• UDI-Public: 00841542109857
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 06/24/2021

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: 09/30/2022
• Device Model Number: TMICL13.2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 10/15/2021
• 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#-1434040.; INJECTOR MODEL-MSI-PF, LOT#-1505169.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR