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

Model Number	VTICM5_13.2
Medical Device Problem Codes	Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583); Optical Problem (3001)
Health Effect - Clinical Codes	Blurred Vision (2137); Halo (2227)
Date of Event	10/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight: unk.Patient ethnicity: unk.Patient race: unk.Explant date: unk.Work order search: no similar complaint was reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens, -11.50/+2.0/088 (sphere/cylinder/axis) into the patients right eye (od) on (b)(6) 2022.The lens had excessive vaulting and the patient experienced glare/haloes and blurred vision.The lens remained implanted.The cause of the event was unknown.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
B5: the lens was removed and replaced with a smaller size lens.The problem was resolved.The post-op results were vault is 75%, ucva 20/100, bcva 20/80, no edema and ac is clear.At the (b)(6) 2022 post-op visit, the patient was ucva 20/70 -2 @ distance and near was cf.His refraction was +1.25 -0.50 x 077, bcva 20/70 and the vault was at 100%.Patient will return for a yag pc on (b)(6) 2023 due to pigment dusting across the icl.The patient is doing well.Claim # (b)(4).
Additional Manufacturer Narrative
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: 15847565
• Report Number: 2023826-2022-04169
• Device Sequence Number: 5076732
• Product Code: QCB
• UDI-Device Identifier: 00841542116800
• UDI-Public: 00841542116800
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/24/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: VTICM5_13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2022
• Supplement Date Received by Manufacturer: 12/12/2022; 02/09/2023
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 01/09/2023; 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2022
• 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 # 1577143.; FOAM TIP PLUNGER MODEL FTP - LOT # 1583636.; INJECTOR MODEL MSI-PF - LOT # UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR
• Patient Sex: Male