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

Model Number	MICL13.7
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); No Code Available (3191)
Date of Event	12/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.7mm, micl13.7, -6.5 diopter, implantable collamer lens into the patient's eye on (b)(6) 2018.Elevated iop (intraocular pressure) without pupil block and angle closure was observed, date assessed: (b)(6) 2018.Lens remains implanted, surgeon had planned to exchange the lens on (b)(6) 2018 for a shorter length lens but the surgery was postponed by the patient and has not rescheduled.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Additional data: the reporter indicated that the surgeon implanted a 13.7mm, micl13.7, -6.5 diopter, implantable collamer lens into the patient's eye on (b)(6) 2018.Elevated iop (intraocular pressure) without pupil block and angle closure was observed, date assessed: (b)(6) 2018.The lens was removed on (b)(6) 2019 and replaced with a shorter length lens.It was reported that the replacement lens resolved the problem and the patient is fine.The explanted lens was discarded and will not be returned.Additional information has been requested.If additional information is received a supplemental medwatch report will be submitted.Secondary surgical intervention, explant.(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: 8219260
• Report Number: 2023826-2019-00044
• Device Sequence Number: 197539
• Product Code: MTA
• UDI-Device Identifier: 00841542103497
• UDI-Public: 00841542103497
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 12/05/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: MICL13.7
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 02/11/2019
• 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
• Patient Age: 25 YR