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

Device Problems Inadequacy of Device Shape and/or Size (1583); No Apparent Adverse Event (3189)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Age - race: unk.(expiration date): unk, no serial number reported.Implant date: unk.(device manufacturing date): unk, no serial number reported.Claim # (b)(4).

Event Description

The reported indicated that the surgeon will be doing a lens exchange on a patient who has an iris cyst.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

Per updated information the doctor stated that the cyst was something the patient had and was not caused by the icl.Lens was removed due to sizing, 200% vault.Patient is doing good.Claim # (b)(4).

Manufacturer Narrative

B5 - "a surgeon email on 06-jun-2022 states the patient was re-operated with an unknown icl placed horizontally.The patient visual acuity is noted as 'she is doing very well with 20/20 uncorrected vision in both eyes.'" should be added to the initial mdr.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: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 12808870
• MDR Text Key: 280971067
• Report Number: 2023826-2021-04335
• 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,Followup
• Report Date: 09/27/2021

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 11/15/2021
• Supplement Dates Manufacturer Received: 12/21/2021; 06/06/2022
• Supplement Dates FDA Received: 05/17/2022; 06/07/2022
• 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
• Treatment: UNK.
• Patient Outcome(s): Required Intervention