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

Model Number	MICL13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); No Code Available (3191)
Date of Event	08/31/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by manufacturer? no - lens not returned.(b)(4).
Event or Problem Description
The reporter stated the surgeon implanted a 13.2mm micl13.2 implantable collamer lens, -12.0 diopter, in the patient's eye on (b)(6) 2016.At a post-op visit on (b)(6) 2016, the surgeon noted an increase in the ocular pressure and lens was cloudy.The surgeon attempted to re-position the lens but with no success.The lens was explanted and a shorter lens was implanted.There were no complications.
Additional Manufacturer Narrative
Correction - the reporter indicated there was no increase in intraocular pressure.Additional information received - the reporter indicated the lens was explanted on (b)(6) 2016 from the patient's right eye (od).The lens was explanted due to excessive vaulting, narrowing of the angle and shallowing of the anterior chamber depth.The patient had a distorted pupil due to crowded angle.The lens exchange resolved the problem.The patient is doing excellent and the post-op visual acuity was 20/25.(b)(4).
Additional Manufacturer Narrative
(b)(4).

• 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: 5983954
• Report Number: 2023826-2016-01325
• Device Sequence Number: 13462934
• Product Code: MTA
• UDI-Device Identifier: 00841542103336
• UDI-Public: (01)00841542103336(17)180228
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2016

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: 02/28/2018
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/31/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/28/2016
• Supplement Report FDA Received Date: 10/12/2016; 12/08/2016
• 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: 31 YR