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

Model Number	MICL 13.2
Medical Device Problem Codes	Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583); Optical Problem (3001)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227); No Code Available (3191)
Date of Event	11/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lens was returned dry, in small container.Visual inspection found no visible damage to lens.(b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm, micl13.2, -11.5 diopter, implantable collamer lens was implanted into the patients right eye (od) on (b)(6) 2018.On (b)(6) 2019 the lens was exchanged for a shorter length lens due to excessive vault, glare/haloes and blurred vision.Prk, refractive treatment was also reported as a secondary intervention.It was reported that the exchange lens resolved the problem.At patients post op follow up visit " glare at night "and " s/p prk doing better, much better icl vault" was noted.In the reporters opinion the cause of this event was icl (high vault causing secondary aberrations, refractory to contact lens correction).
Additional Manufacturer Narrative
Corrected data: d6: should be "(b)(6) 2018" in the initial mdr.Additional information: h6- work order search: no additional similar complaint type events within associated lots were found.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: 9634632
• Report Number: 2023826-2020-00203
• Device Sequence Number: 19625842
• Product Code: MTA
• UDI-Device Identifier: 00841542103329
• UDI-Public: 00841542103329
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2019

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: 06/30/2019
• 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: 01/21/2020
• Initial Date Received by Manufacturer: 12/30/2019
• Supplement Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 05/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL: SFC-45 WITH FTP, LOT # UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR