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

Model Number	VTICM5_12.6
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 12.6mm vticm5_12.6 -14.00/2.5/074 (sphere/cylinder/axis) implantable collamer lens was implanted into the patient's left eye (os) on (b)(6) 2022.On (b)(6) 2022 lens repositioning was performed due to lens rotation not associated to a low vault but it did not resolve the problem.The lens was explanted and a replacement lens of longer length was later implanted.It was reported that the problem resolved.
Additional Manufacturer Narrative
Type of investigation - lens work order search: no similar complaint type events reported for units within the same lot.Claim#: (b)(4).
Additional Manufacturer Narrative
H3- device evaluation: lens was returned dry with residue/debris on product , inside a specimen cup.Visual inspection found the haptic torn.Claim # (b)(4).
Additional Manufacturer Narrative
Corrected information: b5- the reporter indicated the surgeon implanted a 12.6mm vticm5_12.6 implantable collamer lens of diopter -14.00/+2.50/074 (sphere/cylinder/axis) into the left eye (os) on (b)(6) 2022.The patient experienced a rotation not associated with a low vault.On (b)(6) 2022 the lens was repositioned but that did not resolve the problem.On (b)(6) 2022 the lens was explanted and later replaced with the same model, longer length and the problem was resolved.The reporter indicated that the cause of the event was "patient related factors - lens rotated from original position, lens was rotated manually to correct position on (b)(6) 2022 & subsequently rotated back".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: 16032297
• Report Number: 2023826-2022-04637
• Device Sequence Number: 7184402
• Product Code: QCB
• UDI-Device Identifier: 00841542115551
• UDI-Public: 00841542115551
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/23/2022

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: 08/31/2024
• Device Model Number: VTICM5_12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 11/23/2022
• Supplement Date Received by Manufacturer: 04/13/2023; 11/28/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 08/19/2023; 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2022
• 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 # UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR
• Patient Sex: Female