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

Model Number	MICL13.2
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); No Code Available (3191)
Date of Event	03/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information was received.The reporter stated the surgeon implanted a 13.2mm micl13.2 implantable collamer lens, -14.0 diopter, in the patients right eye (od) on (b)(6) 2017.The lens was exchanged for a shorter length lens on (b)(6) 2017 due to elevated intraocular pressure, excessive vault, narrowing of the angle, and shallowing of the acd.Additional surgical intervention ( laser peripheral iridectomy) and medical intervention (diamox) were performed/prescribed.The patients post-op uncorrected visual acuity was 20/50 residual astigmatism at 1 day post -op of icl exchange.The reporter stated that the event was product-related.(b)(4).Implanted date was corrected to (b)(6) 2017 , lens exchange was a secondary surgery.Claim# (b)(4).
Event or Problem Description
The reporter stated that a 13.2mm micl13.2 implantable collamer lens, -14.0 diopter, was explanted and replaced with a shorter length lens within the same surgery because it was causing pressure.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Additional information was received.The reporter stated the surgeon implanted a 13.2mm micl13.2 implantable collamer lens, -14.0 diopter, in the patients right eye (od) on (b)(6) 2017.The lens was exchanged for a shorter length lens on (b)(6) 2017 due to elevated intraocular pressure, excessive vault, narrowing of the angle, and shallowing of the acd.Additional surgical intervention ( laser peripheral iridectomy) and medical intervention (diamox) were performed/prescribed.The patients post-op uncorrected visual acuity was 20/50 residual astigmatism at 1 day post -op of icl exchange.The reporter stated that the event was product-related.(b)(4).Implanted date was corrected to (b)(6) 2017 , lens exchange was a secondary surgery.Claim# (b)(4).
Additional Manufacturer Narrative
Previous implant date, (b)(6) 2017, is incorrect.The correct implant date is (b)(6) 2017.(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: 6524681
• Report Number: 2023826-2017-00625
• Device Sequence Number: 16460849
• Product Code: MTA
• UDI-Device Identifier: 00841542103374
• UDI-Public: (01)00841542103374(17)181031
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2017

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: 10/31/2018
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/31/2017
• Supplement Date Received by Manufacturer: Not provided; 08/11/2017
• Initial Report FDA Received Date: 04/26/2017
• Supplement Report FDA Received Date: 06/23/2017; 08/14/2017
• 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: 21 YR