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

Model Number	MICL 13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Headache (1880); Intraocular Pressure Increased (1937); No Code Available (3191)
Date of Event	07/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A work order search was performed and no similar complaints were found.(b)(4).
Event or Problem Description
The reporter stated that the surgeon implanted a 13.2mm micl13.2, -9.5 diopter, implantable collamer lens in the patients right eye (od) on (b)(6) 2017.The lens was exchanged for a smaller size lens on (b)(6) 2017 due to high vault, elevated iop, and narrowing of the angle.Headache was also reported as an additional symptom.The reporter stated that the cause of the event was unknown.The patients post-op bcva was 20/20.Additional information has been requested, if additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
The lens was returned in a liquid present in a vial.Visual inspection found a piece of haptic missing from the lens.(b)(4).
Additional Manufacturer Narrative
The patient's post-op bcva was 20/20" is incorrect.The patient's post-op refraction bcva was found to be 20/20 on (b)(6) 2017 before the exchange.Concomitant medical products: injector, cartridge and injector system model are known.(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 6765864
• Report Number: 2023826-2017-01265
• Device Sequence Number: 1490299
• Product Code: MTA
• UDI-Device Identifier: 00841542103282
• UDI-Public: 00841542103282
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/06/2017

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: 05/31/2018
• Device Model Number: MICL 13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/06/2017
• Supplement Date Received by Manufacturer: 08/15/2017; 09/21/2017
• Initial Report FDA Received Date: 08/03/2017
• Supplement Report FDA Received Date: 08/22/2017; 09/21/2017
• 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: 35 YR