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

Model Number	MICL13.7
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Corneal Edema (1791); Endophthalmitis (1835); Hypopyon (1913); Intraocular Pressure Increased (1937); Pupillary Block (2026); Vitrectomy (2643); No Code Available (3191)
Date of Event	03/11/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by manufacturer: lens implanted.(b)(4).
Event or Problem 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.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Additional information received - the customer reported the lens was explanted.

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 5639098
• Report Number: 2023826-2016-00630
• Device Sequence Number: 16380430
• Product Code: MTA
• UDI-Device Identifier: 00841542103527
• UDI-Public: (01)00841542103527(17)161231
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Physician
• Device Expiration Date: 12/31/2016
• Device Model Number: MICL13.7
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2016
• Supplement Report FDA Received Date: 07/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 23 YR
• Patient Weight: 91