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

Model Number VTICM5 12.1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Date 10/21/2023

Event Type  Injury  

Event Description

The reporter indicated that a 12.1mm vticm5 12.1 implantable collamer lens of -6.50/2.0/106 (sphere/cylinder/axis) was implanted into the patients right eye (od) on (b)(6) 2023.Rebound post-op inflammation with mid corneal stromal inflammation.Additional postoperative steroid drops were given.Lens remains implanted.Conditions are improving.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

H6-health impact:4644: steroid drops.Investigation type 4110: lens work order search- no similar complaint event(s) within associated lots were found.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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 18183258
• MDR Text Key: 328686831
• Report Number: 2023826-2023-05185
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542112888
• UDI-Public: 00841542112888
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/24/2023

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
• Device Operator: Health Professional
• Device Model Number: VTICM5 12.1
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2023
• Initial Date FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2022
• 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
• Treatment: INJECTOR MODEL: LIOLI-24, LOT# UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR
• Patient Sex: Female