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

Model Number	TMICL 12.6
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight, ethnicity, race: unk.Investigation type (b)(4): lens work order search- no similar complaint event(s) within associated lots were found.Claim #: (b)(4).
Event or Problem Description
The reporter indicated that a 12.6mm tmicl 12.6 implantable collamer lens of -12.0/2.0/087 (sphere/cylinder/axis) was implanted into the patient's right eye (od) on (b)(6) 2022.Excessive vault and elevated iop was observed.On (b)(6) 2022 the lens was removed and on the same day a replacement lens of spherical and shorter length was implanted.The replacement lens did not resolve the problem.See mfr # 2023826-2022-01552 for replacement lens.
Additional Manufacturer Narrative
Corrected data: h6-type of investigation code : 10 in previous mdr should be corrected to 4110.Additional information: h6- device evaluation: lens returned in a micro-centrifuge vial in liquid.Visual inspection found optic torn.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
• MDR Report Key: 14403295
• Report Number: 2023826-2022-01524
• Device Sequence Number: 5500212
• Product Code: QCB
• UDI-Device Identifier: 00841542107143
• UDI-Public: 00841542107143
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2022

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: 03/31/2023
• 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: 04/14/2022
• Supplement Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 05/14/2022
• Supplement Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2021
• 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