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

Model Number	VICM5_12.6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Endophthalmitis (1835); Inflammation (1932); Red Eye(s) (2038); Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Claim# (b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted an implantable collamer lens into the patient's right eye (od).The surgeon reports the patient has anterior chamber inflammation with symptoms of mild blurred vision and eye redness 1 month ago that was resolved with short course of prednisolone for 1 week.It was later reported the patient had significant inflammation in the right eye but her vision is still very good 20/20 and iop is 12mmhg.Surgeon notes they started prednisolone then qid.Lens remains implanted.
Additional Manufacturer Narrative
B5 - it was later reported that two months after surgery patient presented with photophobia and mild blurred vision.On examination she was found to have +2 cell and flare (anterior chamber inflammation).Patient was started on steroids with minimal response of inflammation.She also had a systemic workup for uveitis which was negative.An ac tap was performed and sent for cultures and pcr.Cultures were negative and pcr positive for strep pneumoniae.Injection of moxifloxacin was given as well as topical moxifloxacin therapy for 2 weeks.Symptoms improved 2 days after injection and when she was last seen (12/04/23- 2 months post injection of antibiotics), she was asymptomatic with no anterior chamber inflammation.The exact etiology of the inflammation is still unclear and has now resolved.H6- investigation type 4110: lens work order search-no similar complaints reported for units within the same lot.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.Claim #: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 17980259
• Report Number: 2023826-2023-04701
• Device Sequence Number: 14079741
• Product Code: MTA
• UDI-Device Identifier: 00841542119191
• UDI-Public: 00841542119191
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/11/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: VICM5_12.6
• 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: 10/11/2023
• Supplement Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown