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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hematoma (1884)

Event Type  Injury  

Manufacturer Narrative

Expiration date - unk.Device evaluated by manufacturer? no.(b)(4).Lens not returned.

Event Description

A patient reported had an icl implantable collamer lens implanted in his right eye (od).Soon after, the patient had a hematoma form on his eye and it lasted several days.The patient reported the eye has since healed and is seeing fairly well out of that eye.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch report will be submitted.

Manufacturer Narrative

Method: medical review.Results: per medical review - the patient reported that he had experienced "hematoma formed over eye" that lasted several days following icl implantation.No medical or surgical intervention, and no loss of bcva were reported.The issue resolved ("hematoma healed").The patient wears contact lens in the fellow eye.It should be noted that hematoma refers to bruising of the tissue under skin around the eye that usually resolves spontaneously.Because all eye procedures involve some form of manipulation on eyelid (no matter how slight), there is a risk of forming a hematoma.Conclusion: based on the complaint history and medical review, a specific root cause of the event could not be determined.(b)(4).

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: 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: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 5221698
• MDR Text Key: 31072987
• Report Number: 2023826-2015-01522
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 10/14/2015

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: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/14/2015
• Initial Date FDA Received: 11/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2016
• 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