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

Model Number	MICL13.7
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	10/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted that the surgeon implanted a micl13.7, -8.0 diopter, implantable collamer lens in the patient's eye on (b)(6) 2017.It was noticed that the lens was too big.It is unsure if the lens is going to be exchanged for a shorter lens.There is no patient injury.Attempts at obtaining additional information have been unsuccessful.
Additional Manufacturer Narrative
The reporter indicated that the surgeon implanted a micl13.7 implantable collamer lens of -8.0 diopter in the patient's eye on (b)(6) 2017.It was noticed that the lens was too big.There is no patient injury.The lens was explanted.Attempts at obtaining additional information have been unsuccessful.Explanted in 2017.Device evaluation: the lens was returned in a specimen cup with clear surgical residue/ debris on the product.Visual inspection found no visible damage to the lens and presence of clear and red residue on the lens surface.(b)(4).Method: no additional similar complaint type events were found within the associated lot.(b)(4).
Additional Manufacturer Narrative
Date of event: it is corrected from (b)(6) 2017 to (b)(6) 2017.The reporter indicated that the surgeon implanted a micl13.7 implantable collamer lens of -8.0 diopter in the patient's left (os) eye on (b)(6) 2017.The lens was exchanged for a shorter lens on(b)(6) 2017 due to excessive vault, narrowing of angles and shallowing of acd.There was no patient injury.The exchange resolved the problem.(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: 7050893
• Report Number: 2023826-2017-01708
• Device Sequence Number: 1186314
• Product Code: MTA
• UDI-Device Identifier: 00841542103527
• UDI-Public: 00841542103527
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2017

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 04/30/2019
• Device Model Number: MICL13.7
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/25/2017
• Supplement Date Received by Manufacturer: 12/14/2017; 01/15/2018
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 01/10/2018; 01/18/2018
• 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