MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC 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); Blurred Vision (2137); No Code Available (3191)
Date of Event	11/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: lens was returned in liquid, in lens vial.Visual inspection found no visible damage to the lens.Secondary surgical intervention, lens explanted and replaced with shorter lens.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm, -9.5 diopter, implantable collamer lens on (b)(6) 2017.The lens was explanted on (b)(6) 2017 due to vaulting and increased intraocular pressure.A shorter length lens was implanted.Additional information has been requested but none has been forthcoming.If additional information is received , a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
The reporter indicated that the surgeon implanted a 13.2mm -9.5 diopter implantable collamer lens on (b)(6) 2017.The lens was explanted on (b)(6) 2017 due to low vaulting, elevated iop, narrowing of angle, shallowing of acd.The surgeon also performed a secondary yag on (b)(6) 2017.The patient had blurry vision during the time of post-op.Implanted date is corrected to (b)(6) 2017.(b)(4).Corrected data: method: no additional similar complaint type events were found within the associated lot.(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: 7113305
• Report Number: 2023826-2017-01883
• Device Sequence Number: 1379095
• Product Code: MTA
• UDI-Device Identifier: 00841542103282
• UDI-Public: 00841542103282
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2017

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: 04/30/2019
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/16/2017
• Supplement Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 01/10/2018
• 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: 27 YR