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

Model Number VTICM5_12.6

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

Patient Problems Endophthalmitis (1835); Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

A1 - unk.A2 - unk.A3 - unk.A4 - unk.A5 - unk.A6 - unk.B3 - unk.D2 - product code: unk (esubmitter software does not allow for a blank or 'unk' entry).D4 - unk.D6a - unk.H4 - unk.Claim# (b)(4).

Event Description

Reporter indicated that patient eturned to clinic due to ocular discomfort.Noted fibrotic material around the lens and hm vision was observed.The patient was 20/25 on day 1.The vitreous excessed cleaned by b scan.Lens remains implanted.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

Additional information added to form (d4).H6: work order search: no similar complaint type events were reported for units within the same lot.Claim#: (b)(4).

Manufacturer Narrative

Corrected data: b5 - the reporter additionally noted "around day 5 heavy fibrin in anterior chamber.They did antibiotics in vitreous by retina and ac washout the next day recovered to 20/20.No bacteria isolated so far from samples.H6 - health effect clinical code: 4581 - heavy fibrin in the anterior chamber.Claim#: (b)(4).

Manufacturer Narrative

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)
• 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: 18302000
• MDR Text Key: 330176716
• Report Number: 2023826-2023-05513
• Device Sequence Number: 1
• Product Code: MTA
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/20/2023

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
• Device Operator: Health Professional
• Device Model Number: VTICM5_12.6
• 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: 11/20/2023
• Initial Date FDA Received: 12/11/2023
• Supplement Dates Manufacturer Received: 12/11/2023; 01/20/2024; 03/31/2024
• Supplement Dates FDA Received: 12/12/2023; 01/21/2024; 04/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2023
• 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: ACCUJECT LOT# 2381A1.; UNK.
• Patient Outcome(s): Required Intervention