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 Cyst(s) (1800)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

An article from acta ophthalmologica 2022 was received in regard to "block excision and tectonic corneoscleral grafting for epithelial implantation cyst after intraocular contact lens implantation".The article involved a 32-year-old woman with correction of myopia following post bilateral icl placement.Three years later in january 2021, the woman presented with a progressively growing transparent iris cyst in her left eye.Block excision including complete cyst with adjacent iris, and ciliary body and tectonic corneoscleral graft were successfully performed without uncontrolled rupture of the cyst or further intervention on either lens or icl.One day post-op, iop was 5 mmhg and ucva was 0.7 logmar.Eight months after cyst removal surgery, crystalline lens remained clear and icl remained well centered.Since icl implantation was anecdotally uneventful, minor ingrowth of conjuctival epithelium through an imperfect tunnel is suspected.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

Corrected data: b5- "eight months after cyst removal surgery crystalline lens remained clear and icl remained well centered.Pupilloplasty was also performed." 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: 14654834
• MDR Text Key: 294859417
• Report Number: 2023826-2022-01796
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/13/2022

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: 05/13/2022
• Initial Date FDA Received: 06/10/2022
• Supplement Dates Manufacturer Received: 08/21/2022
• Supplement Dates FDA Received: 08/21/2022
• 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: UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female