MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); 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); No Code Available (3191)
Date of Event	11/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight, ethnicity, race: unk.(b)(4).Lens work order search: no similar complaint type events reported for units within the same lot.Claim# 430811.
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm tmicl13.2 lens, -14.5/+1.5/074 (sphere/cylinder/axis) into the patient's left (os) eye on (b)(6) 2019.On (b)(6) 2019 the lens was exchanged with a shorter lens due to excessive vault, pupil block, and elevated iop.Immediate postop results were good following the exchange.Prior to exchange the surgeon had performed a release of fluid via paracentesis and had the patient on "maximal medical therapy.".
Additional Manufacturer Narrative
Patient's age: (b)(6) 1983.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: 9512611
• Report Number: 2023826-2019-02422
• Device Sequence Number: 2080676
• Product Code: QCB
• UDI-Device Identifier: 00841542109659
• UDI-Public: 00841542109659
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2019

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: 09/30/2021
• Device Model Number: TMICL13.2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 02/20/2020
• 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: 36 YR