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

Model Number	TMICL12.6
Medical Device Problem Codes	Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cataract (1766)
Date of Event	06/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight: unk.Ethnicity: unk.Race: unk.(b)(4).Claim # (b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 12.6mm tmicl12.6 implantable collamer lens, -10.00/+1.0/016 (sphere/cylinder/axis), in the patients eye on (b)(6) 2021.The lens was explanted on (b)(6) 2022 due to a cataract developed.The lens was replaced with an iol.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
H3 - device evaluation: the lens was returned in liquid in a microcentrifuge vial with debris on the lens.Visual inspection found no visible damage to the lens with debris on the lens.Claim #: (b)(4).
Additional Manufacturer Narrative
H6: health impact - additional surgery: 4625 - phacoemulsification (cataract surgery), iol implanted.B3: date of event (b)(6) 2022.B5: the reporter indicated the surgeon implanted a 12.6mm tmicl12.6 implantable collamer lens, -10.00/+1.0/016 (sphere/cylinder/axis), in the patients right eye (od) on (b)(6) 2021.The lens was explanted on (b)(6) 2022 due to low vaulting and the development of a cataract (nuclear sclerotic), observed on (b)(6) 2022.Phacoemulsification (cataract surgery) was performed and an iol was implanted.The problem was resolved.The cause of the event was due to the device.D6b: (b)(6) 2022.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: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 15506297
• Report Number: 2023826-2022-03329
• Device Sequence Number: 12701430
• Product Code: QCB
• UDI-Device Identifier: 00841542106849
• UDI-Public: 00841542106849
• 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: 2021
• 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,Followup
• Report Date (Section B): 09/16/2022

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: TMICL12.6
• 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: 09/16/2022
• Supplement Date Received by Manufacturer: 10/21/2022; 12/15/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 11/09/2022; 12/23/2022
• 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 MODEL FTP - LOT # UNK; INJECTOR MODEL MSI-PF - LOT # UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male