MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF MULTIPIECE IOL; INTRAOCULAR LENS

Model Number MA60BM

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problem Visual Disturbances (2140)

Event Date 02/22/2001

Event Type  Injury  

Event Description

A case report on spontaneous disinsertion of multipiece foldable acrylic intraocular lens (iol) haptic in a 14 year old girl stated that after iol implantation, she presented with monocular diplopia.The iol with one attached haptic had dislocated into the anterior chamber, and a disinserted haptic was lying in the inferior anterior chamber.The iol was removed and replaced with a non-company lens in a secondary procedure.

Manufacturer Narrative

The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.The root cause for the haptic disinsertion could not be determined.This file was opened from a literature report: "spontaneous disinsertion of a multipiece foldable acrylic intraocular lens haptic 3 and 12 months after implantation.The event for this file took place in 2001.The product was not returned.The lens was indicated implanted in the ciliary sulcus (b)(6) of 2000.Per the instruction for use (ifu): company's posterior chamber intraocular lenses are indicated for the replacement of the human lens to achieve visual correction of aphakia in adult patients following cataract surgery when extracapsular cataract extraction or phacoemulsification are performed.These lenses are intended for placement in the capsular bag.Per the report: one week postoperatively, the pc iol was stable in the ciliary sulcus in front of the capsular rim and the retina remained attached.On (b)(6) 2001, the uncorrected visual acuity was 20/25.(b)(6) 2001, the patient presented with a 1-week history of monocular diplopia in the right eye.There was no history of ocular trauma or excessive physical activity.The iol with 1 attached haptic had dislocated into the anterior chamber, and a disinserted haptic was lying in the inferior anterior chamber angle.Four days later, a rigid single-piece non-company, 15.0 diopter lens was exchanged for the company, 15.5 diopter lens.The patient has had no problems with the iol.Although the patient had a recurrence of acute retinal necrosis (arn) in the right eye in (b)(6) 2001, the arn responded well to treatment and the patient¿s bcva was 20/20 in the right eye in (b)(6) 2003.The report discussed potential causes.It is possible that the pc iol might not have dislocated or haptic disinsertion occur had the optic been located securely within the capsular bag and covered anteriorly with the rim of the anterior capsule.The complication could also have been related to accommodative effort if the fellow eye was pseudophakic.Given that the cases involved young patients, it is possible that in scotopic conditions the pupillary diameters were large enough to permit movement of the pc iol optic through the pupillary plane.The degree of this movement, along with existing intrinsic weakness or haptic¿optic junction fatigue, may have been sufficient to cause disinsertion of the haptic from the optic.No further information is available as this event occurred 22 years ago.Yong ming por, mrcsed, mrcophth, mmed (ophth), soon-phaik chee, frcs (glasg) frcophth, spontaneous disinsertion of a multipiece foldable acrylic intraocular lens haptic 3 and 12 months after implantation, (b)(6) 2003, j cataract refract surg¿vol 30, may 2004.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF MULTIPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 17020564
• MDR Text Key: 316136771
• Report Number: 1119421-2023-00995
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2005
• Device Model Number: MA60BM
• Device Catalogue Number: MA60BM.155
• Device Lot Number: 576859
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2000
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SINSKEY HOOK
• Patient Outcome(s): Required Intervention
• Patient Age: 15 YR
• Patient Sex: Female