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

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

Patient Problems Endophthalmitis (1835); Uveitis (2122)

Event Type  Injury  

Event Description

The reporter indicated that the surgeon implanted an implantable collamer lens into the patient's right eye (os).The surgeon reports the patient has uveitis 2 months after implantation, and may have chronic endophthalmitis due to the presence of large kp's and a small plaque in the posterior aspect of the evo icl.Lens remains implanted.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Corrected data: b5: the reporter indicated that the surgeon implanted an implantable collamer lens into the patient's unknown eye.Reportedly, "i believe i may also have a case of p.Acnes endophthalmitis.I will keep in touch".Lens remains implanted.Additional information has been requested but none has been forthcoming.E1: (b)(6).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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 18007849
• MDR Text Key: 326554384
• Report Number: 2023826-2023-04813
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/14/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2023
• Initial Date FDA Received: 10/25/2023
• Supplement Dates Manufacturer Received: 12/29/2023
• Supplement Dates FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other