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	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No similar complaint type events reported for units within the same lot.(b)(4).
Event or Problem Description
A 13.2mm micl13.2 implantable collamer lens, -13.5 diopter, was implanted into the patient's eye.The surgeon reports he intends to exchange the lens with a 13.7mm lens, stating "there is not inadequate vault" of the lens.Attempts to obtain additional information have not been successful.
Additional Manufacturer Narrative
Patient code 3191: no code available (secondary surgery, lens exchange).On (b)(6) 2019 the lens was removed and exchanged intraoperatively with a longer length lens due to low vault and the problem resolved.The patient is healing nicely.The cause of the event was reported as the device and a patient related factor.Claim#: (b)(4).
Additional Manufacturer Narrative
Device evaluation: lens was returned in a specimen cup in liquid.Visual inspection found a tear on the lens haptic.Claim#: (b)(4).
Additional Manufacturer Narrative
Additional information: the lens was implanted in the right (od) eye.(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: 8941313
• Report Number: 2023826-2019-01569
• Device Sequence Number: 328958
• Product Code: MTA
• UDI-Device Identifier: 00841542103367
• UDI-Public: 00841542103367
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/01/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Initial Date Received by Manufacturer: 08/01/2019
• Supplement Date Received by Manufacturer: 08/28/2019; 11/08/2019; 11/20/2019
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 09/25/2019; 11/14/2019; 12/02/2019
• 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