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

Catalog Number N/A

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

Patient Problem Endophthalmitis (1835)

Event Type  Injury  

Manufacturer Narrative

D2 - product code: unk (esubmitter software does not allow for a blank or 'unk' entry).Manufacturer narrative: a review of the device labeling was completed.The device is contraindicated/prohibited in patients if there is: "(7) suspicion of iritis, iris adhesions, pigment scattering syndrome, pseudoexfoliation syndrome or past history." endophthalmitis was an anticipated adverse event per the same dfu.Since the information provided states the inflammation (endophthalmitis) was most likely caused by the patient related factor of unilateral iritis, it is very likely that the reported event was not device related in origin.Claim#(b)(4).

Event Description

Reportedly one month upon icl implantation the patient presented with endophthalmitis.Concomitant products used during surgery were: opegan as viscoelastic, the staar injector system (msi-pf injector; sfc-45 with foam tip plunger) and, moxifloxacin.The patient was prescribed steroid ophthalmic drops.The cause of the inflammation was attributed to unilateral iritis.No additional information was received to date.The lens remains implanted.

• 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: 19030997
• MDR Text Key: 339216575
• Report Number: 2023826-2024-01377
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2024

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 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: 03/15/2024
• Initial Date FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: No
• 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: CARTRIDGE MODEL#SFC-45, LOT#UNK.; FOAMTIPPLUNGER MODEL#FTP, LOT#UNK.; INJECTOR MODEL#MSI-PF, LOT#UNK.
• Patient Outcome(s): Other