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

Model Number VICM5_13.2

Device Problems Misfocusing (1401); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blurred Vision (2137)

Event Date 11/01/2023

Event Type  Injury  

Event Description

The reporter indicated that a 13.2mm, vicm5_13.2, -8.0 diopter, implantable collamer lens was implanted into the patient's left eye (os) on (b)(6) 2023.Refractive surprise was observed.Lens remains implanted.Cause of the event is reported as patient related factor.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

H6 - work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(6).

Manufacturer Narrative

Additional information: b1: adverse event.B2: required intervention to prevent permanent impairment/damage (devices).B5: the reporter indicated that a 13.2mm vicm5 13.2 implantable collamer lens of -8.00 diopter was implanted into the left eye (os) on (b)(6) 2023.Refractive surprise was reported.On (b)(6) 2024, the lens was removed and on the same day a replacement lens of the same size and different diopter was implanted.The replacement lens resolved the problem.D6b: on (b)(6) 2024.Claim#: (b)(4).

Manufacturer Narrative

H3 - device evaluation: the lens was not returned in a box, lens was returned in liquid in a specimen cup.Visual inspection found haptic torn.

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC 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: 18788747
• MDR Text Key: 336339185
• Report Number: 2023826-2024-00759
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542119375
• UDI-Public: 00841542119375
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2024

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
• Device Operator: Health Professional
• Device Model Number: VICM5_13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 02/28/2024; 03/25/2024
• Supplement Dates FDA Received: 03/06/2024; 05/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2023
• 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
• Treatment: INJECTOR MODEL#LIOLI-24,LOT#UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male