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

Model Number VTICM5_13.7

Device Problem No Apparent Adverse Event (3189)

Patient Problem Corneal Edema (1791)

Event Type  malfunction  

Event 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.

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).

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)
• Type of Device: 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
• MDR Text Key: 331712943
• Report Number: 2023826-2023-05832
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00840311314515
• UDI-Public: 00840311314515
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: VTICM5_13.7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 02/28/2024
• Supplement Dates FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male