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

Model Number	TMICL12.6
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Pupillary Block (2026)
Date of Event	05/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm tmicl12.6 lens, -16.0/+1.0/068 (sphere/cylinder/axis) into the patient's right (od) eye on (b)(6) 2021.On (b)(6) 2021 the lens was explanted and replaced with a shorter lens due to excessive vault, pupil block, and elevated iop.The problem is resolved.
Additional Manufacturer Narrative
B5-additional info: "despite all calculations indicating 12.6 or even 13.2 the lens was clearly oversized in the eye and a 12.1 was needed.There was nothing in the preoperative evaluation that should have indicated that result." claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 11942691
• Report Number: 2023826-2021-01763
• Device Sequence Number: 4113305
• Product Code: QCB
• UDI-Device Identifier: 00841542107686
• UDI-Public: 00841542107686
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 05/14/2021

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: TMICL12.6
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 07/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR