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

Model Number	MICL 13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Pupillary Block (2026); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 13.2mm micl13.2 -11.50 diopter implantable collamer lens was implanted into the patients right eye (od) on (b)(6) 2022.The patient experienced excessive vault, pupil block, angle closure, elevated intraocular pressure, unreactive (fixed) pupil, and blurred vision.Additional medical intervention (aqueous suppressants and diomox) were prescribed.On (b)(6) 2022 the lens was exchanged for a shorter length, same model and power lens.It was reporter that the exchange resolved the problem.However, it was also reported that the vault is still high.For status of the eye the reporter stated " quiet, comfortable, good vision, happy." in the reporters opinion the device and patient-related factor is the cause of this event.
Additional Manufacturer Narrative
(b)(4).Lens work order search: no similar complaint type events reported for units within the same lot.Claim#: (b)(4).
Additional Manufacturer Narrative
Corrected data: b5- "the reporter indicated that a 13.2mm micl13.2 -11.50 diopter implantable collamer lens was implanted into the patient's right eye (od) on (b)(6) 2022.The patient experienced excessive vault, pupil block, angle closure, angle closure, elevated intraocular pressure, unreactive (fixed) pupil and blurred vision.Additional medical intervention (aqueous suppressants and diomox) was prescribed.On (b)(6) 2022 the lens was exchanged with a shorter length lens and problem resolved.Status of the eye was reported as "quiet, comfortable, good vision, happy".However it was also reported the vault is still high.In the reporter's opinion the deice and patient related factor is the cause of this event." h6- health effect: impact code- 4627 should be corrected to 4629.D6b- (b)(6) 2022 corrected to (b)(6) 2022.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: b5- "the reporter indicated that a 13.2mm micl13.2 -11.50 diopter implantable collamer lens was implanted into the patient's right eye (od) on (b)(6) 2022.The patient experienced excessive vault, pupil block, angle closure, angle closure, elevated intraocular pressure, unreactive (fixed) pupil and blurred vision.Additional medical intervention (aqueous suppressants and diomox) was prescribed.On (b)(6) 2022 the lens was explanted.On (b)(6) 2022 the lens was replaced with a shorter length lens and problem resolved.Status of the eye was reported as "quiet, comfortable, good vision, happy".However it was also reported the vault is stil high.In the reporter's opinion the deice and patient related factor is the cause of this event." h6- health effect: impact code- 4627.D6b- (b)(6) 2022.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
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 14493429
• Report Number: 2023826-2022-01673
• Device Sequence Number: 12221639
• Product Code: MTA
• UDI-Device Identifier: 00841542103329
• UDI-Public: 00841542103329
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/25/2022

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: 09/30/2022
• Device Model Number: MICL 13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2022
• Supplement Date Received by Manufacturer: 08/23/2022; 08/24/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 08/23/2022; 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INJECTOR MODEL: LIOLI-24, LOT # UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Patient Sex: Female