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

Model Number	MICL13.7
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Results code(s): (operational problem): visual inspection of the returned product found a piece of the lens optic and one haptic torn off.The lens was returned in liquid.Conclusions code(s): (unable to confirm complaint): based on the complaint history, work order search and product evaluation, a specific root cause of the event could not be determined.(b)(4).
Event or Problem Description
The reporter stated the surgeon implanted a 13.7mm micl13.7 implantable collamer lens, -13.5 diopter, in the patient's eye on (b)(6) 2016.The lens was explanted due to increased vault and angle closure.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch report will be submitted.

• 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: 5902492
• Report Number: 2023826-2016-01159
• Device Sequence Number: 22465
• Product Code: MTA
• UDI-Device Identifier: 00841542103633
• UDI-Public: (01)00841542103633(17)170430
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/25/2016

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: 04/30/2017
• Device Model Number: MICL13.7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2016
• Initial Report FDA Received Date: 08/24/2016
• 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: 27 YR