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

Model Number	VTICM5_13.7
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Corneal Edema (1791)
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated that a 13.7mm vticm5_13.7 implantable collamer lens of -8.50/1.0/147 (sphere/cylinder/axis) was implanted into the patients right eye (od) on (b)(6) 2023 as a replacement lens to address low vault with rotation.For status of the eye the reporter stated that the eye was first day postoperative with corneal edema and miosis from surgery.It was reported that at the next appointment on (b)(6) 2023 pupil was still in miosis from myostst.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
H6- health effect- clinical code 4581: miosis.H6 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
The reporter indicated the surgeon implanted a 13.7mm vticm5_13.7 implantable collamer lens of diopter -8.5/+1.0/130 (sphere/cylinder/axis) into the patient's right eye (od) (b)(6) 2023 as a replacement lens.The patient experienced corneal oedema, miosis and probable low vault.Reportedly "eye was first day postoperative with corneal edema and miosis from surgery" and "pupil still in miosis from myostat, which is also the probable explanation of the low vault".The lens remains implanted.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 ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 18419305
• Report Number: 2023826-2023-05832
• Device Sequence Number: 20523421
• Product Code: QCB
• UDI-Device Identifier: 00840311314515
• UDI-Public: 00840311314515
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: VTICM5_13.7
• 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: 12/05/2023
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2023
• 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
• Patient Sex: Male