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

Model Number	VTICM513.2
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 13.2mm vticm513.2 implantable collamer lens of -3.50/1.0/178 (sphere/cylinder/axis), was implanted into the patient's right eye (od).Elevated iop with pupillary block and athalamia are reported.
Additional Manufacturer Narrative
A4-a6:unk.H6: work order search: no similar complaints within associated lots were found.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: b5: it is reported that the patient has somewhat closed angles and the vault is a little high.Patient is doing fine.Claim# (b)(4).
Additional Manufacturer Narrative
B5: reportedly, "it has somewhat closed angles and the vault is a little high." it was later reported, "over the days the patient improved somewhat with pilocarpine.Has swapped to a smaller lens for high vault." regarding causality it was reported that "he tells me that hypothalamia thinks it would be because the lens was large or implanted irregularly.He put the patient back in thinking that the lens could be stuck to the iris.When he manipulated it he thought it had turned out well, but upon inspection he realized that it had a high vault".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 91016
• Manufacturer Contact: joselene muniz ; 800 royal oaks dr. suite:210; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 18952368
• Report Number: 2023826-2024-01320
• Device Sequence Number: 7085108
• Product Code: QCB
• UDI-Device Identifier: 00840311311057
• UDI-Public: 00840311311057
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/11/2024

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 Expiration Date: 06/30/2026
• Device Model Number: VTICM513.2
• 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: 03/11/2024
• Supplement Date Received by Manufacturer: 04/02/2024; 04/16/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 04/03/2024; 04/16/2024
• Date Device Manufactured: 07/17/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown