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

Model Number MICL13.7

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Corneal Edema (1791); Endophthalmitis (1835); Hypopyon (1913); Intraocular Pressure Increased (1937); Pupillary Block (2026); Vitrectomy (2643); No Code Available (3191)

Event Date 03/11/2016

Event Type  Injury  

Manufacturer Narrative

Device evaluated by manufacturer: lens implanted.(b)(4).

Event Description

The reporter stated the surgeon implanted a 13.7mm micl13.7 implantable collamer lens, -8.0 diopter, in the patient's right eye (od) on (b)(6) 2016.On (b)(6) 2016 the patient presented with post-op endophthalmitis.The patient underwent a vitrectomy with antibiotic injection.The patient experienced hypopyon, pupillary block, with elevated intraocular pressure and corneal edema.The lens remains implanted and the surgeon indicated the cause of the event was not device related, most likely due to introduction of bacteria during or after surgery.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received - the customer reported the lens was explanted.

• 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: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 5639098
• MDR Text Key: 44663791
• Report Number: 2023826-2016-00630
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542103527
• UDI-Public: (01)00841542103527(17)161231
• 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
• Report Date: 04/13/2016

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: 12/31/2016
• Device Model Number: MICL13.7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2016
• Initial Date FDA Received: 05/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2015
• 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: 23 YR
• Patient Weight: 91