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

Model Number	VTICM5_12.6
Medical Device Problem Codes	Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	12/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product is not marketed in the us.No similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that a 12.6mm, vticm5_12.6, -10.00/1.0/082 (sphere/cylinder/axis), implantable collamer lens was implanted into the patients left eye (os) on (b)(6) 2020.On (b)(6) 2020 the lens was exchanged for a longer length lens due to low vault with rotation and refractive surprise this exchange resolved the problem.
Additional Manufacturer Narrative
H3- device evaluation: lens was returned in a micro centrifuge vial in liquid.Visual inspection found no visible damage to the lens.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: 11122217
• Report Number: 2023826-2021-00072
• Device Sequence Number: 15749935
• Product Code: QCB
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: VTICM5_12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 04/17/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 05/06/2021
• 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 W/FTP, LOT# UNK; INJECTOR MODEL: MSI-PF, LOT# UNK; CARTRIDGE MODEL: SFC-45 W/FTP, LOT# UNK; INJECTOR MODEL: MSI-PF, LOT# UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR