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

Model Number	MICL13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Intraocular Pressure Increased (1937); Eye Pain (4467)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The patient reported that he had a 13.2mm, micl13.2, -10.0 diopter, implantable collamer lens implanted into his right eye (od) on (b)(6) 2018.The patient states that he is experiencing chronic eye syndrome since the implant was placed.He indicated that he did not have this prior to the actual surgery.He states that when he tapes his eye shut the condition is not as severe as when he sleeps without the tape, when he sleeps his eye is slightly slit.
Additional Manufacturer Narrative
"chronic eye syndrome" should be changed to "chronic dry eye syndrome." claim#: (b)(4).
Additional Manufacturer Narrative
B5-additional symptoms reported: painful dry eye and elevated iop.H6-investigation findings code corrected.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: b5 - "treatment includes serum tear therapy; moisture chamber goggles; fish oil; and taping of eyelids." should be added.H6 - 4650 - serum tear therapy.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: 8574636
• Report Number: 2023826-2019-00729
• Device Sequence Number: 2039211
• Product Code: MTA
• UDI-Device Identifier: 00841542103299
• UDI-Public: 00841542103299
• Combination Product (Y/N): N
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/03/2019

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: 04/30/2019
• Device Model Number: MICL13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 06/28/2019; 12/09/2020; 07/29/2021
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 06/28/2019; 01/05/2021; 07/30/2021
• 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: Other