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

Model Number	TMICL 12.6
Medical Device Problem Code	Misfocusing (1401)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 12.6mm tmicl 12.6 implantable collamer lens of -12.5/3.5/082 (sphere/cylinder/axis) was implanted into the patients left eye (os) on (b)(6) 2021.The initial lens was explanted and a replacement lens of same model/size and different power was implanted due to refractive surprise.The cause is reported as device "mismarked lens resulted in refractive surprise.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
H6 - type of investigation 3331 - device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.Claim #(b)(4).
Additional Manufacturer Narrative
H3 device evaluation: the lens was returned in liquid in a vial.Visual inspection found haptic torn to the lens.Dimensional inspection found the lens to be within specifications.Functional inspection found that the returned lens did not meet original values measured at the time of manufacturing.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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 15097257
• Report Number: 2023826-2022-02279
• Device Sequence Number: 14730096
• Product Code: QCB
• UDI-Device Identifier: 00841542107242
• UDI-Public: 00841542107242
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/16/2022

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: 05/31/2023
• Device Model Number: TMICL 12.6
• 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: 06/16/2022
• Supplement Date Received by Manufacturer: 09/19/2022; 09/19/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 09/23/2022; 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female