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

Model Number	MICL12.6
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227); No Code Available (3191)
Date of Event	07/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pt info: unk.Event date: unk.(b)(4).Work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 12.6mm micl12.6 implantable collamer lens, -11.5 diopter, in the patients left eye (os) on (b)(6) 2018.The lens was explanted on (b)(6) 2018 and was exchanged for a longer lens.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
Additional data: the reporter indicated the lens was explanted due to low vaulting, lens dislocation/subluxation and glare/halos.The lens was exchanged for a longer lens but the problem was not resolved.After icl exchange the intraocular pressure remained elevated.A secondary yag was performed for enlargement of the peripheral iridectomies.The reporter indicated the lens haptics were posterior to sulcus and optic was against the natural lens, causing anterior subcapsular changes (lens opacity).The reporter indicated the cause of the event was due to patient related factor (the patients anatomy seemed to be the cause of the icl failure).See mfr report # 2023826-2019-00071 for exchanged lens.Claim # (b)(4).
Additional Manufacturer Narrative
Device evaluation: the lens was returned dry, in a specimen cup, with residue on lens.Visual inspection found no visible damage to the lens.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: 8233832
• Report Number: 2023826-2019-00073
• Device Sequence Number: 1745833
• Product Code: MTA
• UDI-Device Identifier: 00841542103053
• UDI-Public: 00841542103053
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/14/2018

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: 04/30/2020
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 02/21/2019; 04/17/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 03/19/2019; 05/16/2019
• 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 AND LOT NUMBER UNK; INJECTOR MODEL AND LOT NUMBER UNK; CARTRIDGE MODEL AND LOT NUMBER UNK; INJECTOR MODEL AND LOT NUMBER UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR