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 Problem Corneal Decompensation (1790)

Event Type  Injury  

Event Description

An article published titled "descemet's membran edothelial keratoplasty for corneal edothelial failure secondary to three types of phaki interaocular lens - retrospective study", noted two eyes (12.5%) had posterior-chamber collamer piols (pc-piol).The purpose of the study was to report corneal endothelial failure secondary to phakic intraocular lens implantation (piol).The article concludes clinically significant visual improvement, and with a high proportion of eyes reaching high levels of bcva and very good refractive outcomes.Reportedly, both eyes presented with corneal decompensation."one presented to us already pseudophakic and with corneal decompensation and we have no information of the lens that had been implanted (the fellow eye had an icl with a central port), and the other patient had an icl of -16.00d.".

Manufacturer Narrative

H6- health effect impact code 4581: endothelial cell failure following piol with subsequent keratoplasty.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 enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 16894693
• MDR Text Key: 314818846
• Report Number: 2023826-2023-01550
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2023
• Initial Date FDA Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK.
• Patient Outcome(s): Required Intervention