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

Model Number	MICL 13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Glaucoma (1875); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).No similar complaint type events were reported for units within the same lot.Claim # (b)(4).
Event or Problem Description
The reporter indicated that a 13.2 mm, micl13.2, -13.5 diopter, implantable collamer lens was explanted from the patients left eye (os) on (b)(6) 2019 due to glaucoma.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
Return date should be corrected to 21-jun-2019 in previous mdr.Claim#: (b)(4).
Additional Manufacturer Narrative
Device evaluation: lens was returned in liquid in a specimen cup.Visual inspection found no visible damage and foreign residue on the lens.(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: 8799452
• Report Number: 2023826-2019-01273
• Device Sequence Number: 3205761
• Product Code: MTA
• UDI-Device Identifier: 00841542103367
• UDI-Public: 00841542103367
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2019

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: 08/31/2019
• Device Model Number: MICL 13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 08/08/2019; 09/20/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 08/09/2019; 09/24/2019
• 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