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

Model Number VTICMO12.6

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

Patient Problems Eye Pain (4467); Swelling/ Edema (4577)

Event Date 02/23/2021

Event Type  Injury  

Manufacturer Narrative

Weight: unk, ethnicity: unk, race: unk.This product is not marketed in the us.Work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).

Event Description

He reporter indicated that a 12.6mm, vticmo12.6, -15.00/1.5/089 (sphere/cylinder/axis), implantable collamer lens was implanted into the patient's right eye (od) on (b)(6) 2020.On (b)(6) 2021 the lens was explanted due to the suspensory ligament of the eye lens that was found to be relaxed, and patient reported severe eye pain, swelling and distension.This resolved the problem.Cause of the event is reported as unknown.Reportedly, "the intraocular lens was implanted into the eye to sink.After the operation, the patient had severe eye pain, swelling and distension, which affected his life.Therefore, the lens was strongly required to be removed.".

• 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: cynthia thai ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 11778992
• MDR Text Key: 262627146
• Report Number: 2023826-2021-01327
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/15/2021

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 Expiration Date: 04/30/2023
• Device Model Number: VTICMO12.6
• 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: 04/15/2021
• Initial Date FDA Received: 05/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 24 YR