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

Model Number	TMICL 13.2
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Optical Problem (3001)
Health Effect - Clinical Codes	Halo (2227); Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight-race: unk.Claim#: (b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm tmicl 13.2 implantable collamer lens of -5.50/1.0/070 (sphere/cylinder/axis) was implanted into the patients right eye on (b)(6) 2022.On (b)(6) 2022 the lens was removed and a replacement lens was implanted of shorter length lens due to excessive vault.The problem was resolved.Cause reported as patient related factor.
Additional Manufacturer Narrative
B5- patient experienced discomfort and halos (residual refractive error)- should have been included on initial mdr.Claim# (b)(4).
Additional Manufacturer Narrative
H3-device evaluation: lens returned dry in wrapped cloth with debris on product.Visual inspection found haptic torn and bent.Debris throughout the lens and one haptic is folded in.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
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 13831603
• Report Number: 2023826-2022-00850
• Device Sequence Number: 1468101
• Product Code: QCB
• UDI-Device Identifier: 00841542108386
• UDI-Public: 00841542108386
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2022

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: 10/31/2022
• Device Model Number: TMICL 13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2022
• Supplement Date Received by Manufacturer: 04/28/2022; 06/14/2022
• Initial Report FDA Received Date: 03/20/2022
• Supplement Report FDA Received Date: 05/28/2022; 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL: SFC-45: LOT# UNK; FOAM TIP PLUNGER (FTP), LOT# UNK; INJECTOR MODEL: MSI-TF, LOT# UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR
• Patient Sex: Female