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

Model Number	VTICMO13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Red Eye(s) (2038); Eye Pain (4467)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Additional information: h6 type of investigation 3331 device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: 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
• Report Number: 2023826-2024-00188
• Device Sequence Number: 2747378
• Product Code: QCB
• UDI-Device Identifier: 00841542121149
• UDI-Public: 00841542121149
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: VTICMO13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/01/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Race: Asian