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

Model Number	MICL 12.6
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); No Code Available (3191)
Date of Event	09/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).No similar complaint type events were reported for units within the same lot.Lens was returned in liquid, in lens vial.Visual inspection found oneof the haptics torn.(b)(4).
Event or Problem Description
The reporter indicated that a 12.6mm micl12.6, -16.0 diopter, implantable collamer lens tore/broke during injection/delivery into the eye on (b)(6) 2019.The reporter reported pre-op and post op endothelial cell count, elevated iop that lasted 4 hours and incision enlargement.The lens was removed and exchanged within the same surgery and the problem resolved.Cause of event was unknown.
Additional Manufacturer Narrative
Claim#: (b)(4).
Additional Manufacturer Narrative
Additional data: the reporter indicated that a 12.6mm micl12.6, -16.0 diopter, implantable collamer lens tore broke during injection/delivery into the eye on (b)(6) 2019.The reporter reported pre-op and post op endothelial cell count, elevated iop that lasted 4 hours and incision enlargement.The lens was removed and exchanged within the same surgery and the problem resolved.Cause of event was unknown.The reporter stated that there was no significant loss of endothelial cells, patients cornea is crystal clear.(b)(4).
Additional Manufacturer Narrative
B5 - post-op the reporter stated patient offered no complaint other then slightly blurred vision, which was resolved by receiving a small prescription for pre-existing corneal astigmatism.H6 - device code: device code: 3189 should be corrected to 2993.Claim#: (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: 9169871
• Report Number: 2023826-2019-01893
• Device Sequence Number: 14160653
• Product Code: MTA
• UDI-Device Identifier: 00841542103145
• UDI-Public: 00841542103145
• Combination Product (Y/N): N
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/09/2019

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: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: MICL 12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 10/13/2019; 12/31/2019; 01/08/2020
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 11/11/2019; 12/31/2019; 01/08/2020
• 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: 29 YR