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

Model Number	MICL13.2
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); No Code Available (3191)
Date of Event	01/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned dry, wrapped in gauze in a ziplock bag.Visual inspection found the haptic torn and bent.There was debris on the lens.(b)(4).No similar complaint was reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 13.2mm micl13.2 implantable collamer lens, -11.5 diopter, in the patients right eye (od) on (b)(6) 2018.The lens was explanted on (b)(6) 2019 due to mechanical failure.The lens was exchanged for a shorter lens.There was no patient injury.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
The reporter indicated the lens was explanted due to excessive vaulting and elevated intraocular pressure.The cause of the event was due to sizing.The lens exchange resolved the problem.Date of event: (b)(6) 2019.Claim#: (b)(4).
Additional Manufacturer Narrative
Corrected data: event- "(b)(6) 2018" in the original mdr should be corrected to "(b)(6) 2018" implanted date should be corrected to (b)(6) 2018 in the original mdr.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: 8356345
• Report Number: 2023826-2019-00279
• Device Sequence Number: 2288169
• Product Code: MTA
• UDI-Device Identifier: 00841542103329
• UDI-Public: 00841542103329
• 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: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/21/2019

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: 01/31/2020
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Initial Date Received by Manufacturer: 01/21/2019
• Supplement Date Received by Manufacturer: 04/30/2019; 05/01/2019
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 04/30/2019; 05/30/2019
• 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 SFC-45 - LOT NUMBER UNK; FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK; INJECTOR MODEL AND LOT NUMBER UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR