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

Model Number	VICM512.6
Medical Device Problem Codes	Misfocusing (1401); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	01/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 12.6mm vicm512.6 implantable collamer lens of a diopter of -9.0 was implanted into the patient's left eye (os) on (b)(6) 2022.On (b)(6) 2023, the lens was removed and replaced for a different model due to refractive surprise and blurred vison.Cause of the event is unknown.Reportedly, "surgical incision induced more astimatism than expected," and "refractive miss - patient had 1.D of astigmastism after spherical icl placement, despite having only 0.5d pre-op so i exchanged the spherical icl for a toric." the status of the eye is reported as, "heathy.".
Additional Manufacturer Narrative
Weight-race:unk.Work order search found no similar complaints.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: d9- returned to manufacturer: "13-mar-2023" should be corrected to "10-mar-2023." b5- "cause is unknown and the device failed to perform as intended." 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.Claim# (b)(4).
Additional Manufacturer Narrative
Additional data: h3- device evaluation: dimensional and functional inspection found the lens to be within specifications.Corrected data: b5- the reporter indicated that the surgeon implanted a 12.6mm vicm5_12.6 implantable collamer lens of diopter -9.00d into the patients left eye (os) on (b)(6) 2022.The patient experienced refractive surprise and blurred vision.Reportedly "1d astigmatism after spherical icl placement, despite having only 0.50d pre-op".On (b)(6) 2023 the lens was exchanged for the different model/ same length and the problem was resolved.Status of the eye is noted as "healthy".The cause for this event was unknown and the device failed to perform as intended.- "surgical incision induced more astigmatism than expected".H6- medical device problem code: "2017" should be removed.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC 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: 16595254
• Report Number: 2023826-2023-00997
• Device Sequence Number: 17257692
• Product Code: MTA
• UDI-Device Identifier: 00841542119160
• UDI-Public: 00841542119160
• 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: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2023

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: 03/31/2024
• Device Model Number: VICM512.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 04/11/2023; 05/25/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 04/11/2023; 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2022
• 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# 1585270; FOAM TIP PLUNGER - LOT# 1581847; INJECTOR MODEL: MSI-PF - LOT# 1546197
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Sex: Female