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

Model Number	VTICM5_12.6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: a2."01-jan-1975" should be removed and "28-jun-1992" should be added.(b)(4).
Additional Manufacturer Narrative
H6- investigation type code: 4110- lens work order search-no similar complaint event(s) within associated lots were found.H11- manufacturer narrative: secondary surgical intervention to remove/replace/reposition the lens is identified in the labeling as a known potential adverse event following icl implantation.Each lens is subjected to a 100% assessment of the power (spherical and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Claim# (b)(4).
Event or Problem Description
A facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced refractive surprise.In a separate visit the lens was exchanged with the same model/ length, different power lens and the problem was resolved.The cause of the event was reported as a patient related factor and the device failed to perform as intended.Cause details provided: "the expected seq from ocos lens calculation was -00.01 with expected astigmatism of +00.10.However, patients post-op refraction was plano -1.25x10.Hence, patient reported blur distance vision".
Additional Manufacturer Narrative
Device evaluation: h3: type of investigation code: 10- device evaluation: the lens was returned in a vial with liquid.Visual inspection found no visible damage.Dimensional and functional inspection found the lens to be within specifications.Correction: b5: a facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced refractive surprise and blurred vision.In a separate visit the lens was exchanged with the same model/ length, different power lens and the problem was resolved.The cause of the event was reported as a patient related factor and the device failed to perform as intended.Cause details provided: "the expected seq from ocos lens calculation was -00.01 with expected astigmatism of +00.10.However, patients post-op refraction was plano -1.25x10.Hence, patient reported blur distance vision" 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
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 19951407
• Report Number: 2023826-2024-03614
• Device Sequence Number: 21068232
• Product Code: QCB
• UDI-Device Identifier: 00840311307807
• UDI-Public: 00840311307807
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2024

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: 02/28/2026
• Device Model Number: VTICM5_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: 08/07/2024
• Supplement Date Received by Manufacturer: 08/11/2024; 10/15/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 08/13/2024; 10/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2023
• 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; MSI-PF, LOT# UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male