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

Model Number VTICMO13.2

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

Patient Problems Inflammation (1932); Red Eye(s) (2038); Eye Pain (4467)

Event Date 01/01/2024

Event Type  Injury  

Manufacturer Narrative

A4: unk.A5: unk.D6b: na.H6: health impact - additional surgery: 4625 - ac washout.H6: health effect impact code - medication required: 4644 - intracameral moxifloxacin; prednisolone acetate; fortified vancomycin/tobramycin; pred-moxi-brom.H6 - work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).

Event Description

The reporter indicated the surgeon implanted a 13.2mm vticmo13.2 implantable collamer lens -16.50/+1.50/105 (sphere/cylinder/axis) into the patient`s right eye (od) on (b)(6) 2023.On the (b)(6) 2024, inflammation was diagnosed (eye was red and painful).Additional diagnostics were performed such as macular oct and vitreous cultures (negative).Subsequent treatments were: ac washout, retina surgeons injected antibiotics.With prescription of additional steroids and antibiotics, by (b)(6) 2024 issues resolved, eye was white and quiet, negative seidel test.According to the surgeon the cause of the event was due to a medical trauma, difficult case; the pupil would not dilate and the iris was manipulated more than normal.The surgeon indicates this was a case of inflammation and not infection.The last information obtained on 23-jan-2024 was stating that patient current post-op protocol was pred-moxi-brom twice a day.The lens remains implanted.

• 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
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 18602470
• MDR Text Key: 334031439
• Report Number: 2023826-2024-00188
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542121149
• UDI-Public: 00841542121149
• 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: 01/01/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: VTICMO13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/01/2024
• Initial Date FDA Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/08/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Race: Asian