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

Device Problem No Apparent Adverse Event (3189)

Patient Problems Dry Eye(s) (1814); Fatigue (1849); Headache (1880); Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/01/2017

Event Type  malfunction  

Manufacturer Narrative

Product code: unk; submitter software does not allow for blank or unk entry.(expiration date): unk, no serial number reported.(device manufacturing date): unk, no serial number reported.(b)(4).

Event Description

(b)(6) complaint: the reporter indicated that the surgeon implanted an implantable collamer lens (icl) into the patients right eye (od).The patient reports "headaches due to dry eye, mgd." attempts to obtain additional information have not been successful.

Manufacturer Narrative

Corrected data: h6 - health effect clinical code: 4581 - eyelid eczema should have been included in initial medwatch report.Additional information: b5 - it was later reported by the patient that they also experienced "bad interaction with head", fatigue (tiredness), discomfort and "pulling of the eye and face".Patient is seeking to have the lens removed.Lens remains implanted.H6 - health effect clinical code: 4581 - "bad interaction with head", "pulling of eye and face".Claim#: (b)(4).

Manufacturer Narrative

Claim#: (b)(4).

Manufacturer Narrative

Claim#: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 10980211
• MDR Text Key: 220635190
• Report Number: 2023826-2020-02954
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: 03/18/2021; 03/18/2021; 04/13/2021
• Supplement Dates FDA Received: 04/08/2021; 04/09/2021; 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1