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

Model Number	VTICM5 12.6
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Blurred Vision (2137); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: required intervention to prevent permanent impairment/damage (devices) the reporter indicated that a 12.6mm vticm5 2.6 implantable collamer lens of -9.00/2.0/069 (sphere/cylinder/axis) was implanted into the left eye (os) on (b)(6) 2024.On (b)(6) 2024 the lens was exchanged for a longer length lens due to low vault.The replacement lens resolved the problem.D6a-(b)(6) 2024.D6b- (b)(6) 2024.Claim# (b)(4).
Additional Manufacturer Narrative
H6-investigation type 4110: lens work order search- no similar complaint event(s) within associated lots were found.Claim#: (b)(4).
Event or Problem Description
The reporter indicated that a 12.6mm vticm5 2.6 implantable collamer lens of -9.00/2.0/069 (sphere/cylinder/axis) was implanted into the left eye (os) on (b)(6) 2024.Blurred vision and refractive surprise was reported.No further information has been provided.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
The reporter indicated that a 12.6mm vticm5 2.6 implantable collamer lens of -9.00/2.0/069 (sphere/cylinder/axis) was implanted into the left eye (os) on (b)(6) 2024.On (b)(6) 2024 the lens was explanted and a replacement lens of a longer length lens was implanted due to low vault with lens rotation, blurred vison, and refractive surprise.The replacement lens resolved the problem.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 muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 19056237
• Report Number: 2023826-2024-01572
• Device Sequence Number: 7068624
• Product Code: QCB
• UDI-Device Identifier: 00840311308361
• UDI-Public: 00840311308361
• 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: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/08/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: VTICM5 12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 03/08/2024
• Supplement Date Received by Manufacturer: 04/19/2024; 05/09/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 05/08/2024; 06/04/2024
• Date Device Manufactured: 01/03/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown