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

Model Number MICL12.6

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Conjunctivitis (1784); Glaucoma (1875); Inflammation (1932); Intraocular Pressure Increased (1937)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patient reported the surgeon implanted a 12.6mm micl12.6 implantable collamer lens, -9.5 diopter, in his right eye (od).The patient reported was prescribed oral medications/eye drops for at least 3 consecutive months due to the inside of his eye was inflamed.Also was prescribed eye drops for 3 consecutive months for high pressure or glaucoma inside the eye.The lens was implanted on (b)(6) 2013.The facility reported they were unable to confirm the patient report.The date of last visit was (b)(6) 2015.The patient had developed viral conjunctivitis at 4 months post-op and this was not related to the icl.The facility reported the patient had no history of elevated iop or glaucoma.The lens remains implanted.

Manufacturer Narrative

Additional data: physician's report stated all patient reported adverse events did not occur.Conjunctivitis did occur but not device related.Corrected data: mfr date: the corrected date is 02/28/2013.(b)(4).

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; haupstrasse 104; nidau, CH-25 60; SZ CH-2560
• Manufacturer (Section G): STAAR SURGICAL COMPANY; haupstrasse 104; nidau, CH-25 60; SZ CH-2560
• Manufacturer Contact: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 6298841
• MDR Text Key: 66428131
• Report Number: 2023826-2017-00208
• 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: 08/18/2016

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
• Device Expiration Date: 01/31/2015
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2016
• Initial Date FDA Received: 02/02/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR