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

Model Number SN60WF

Device Problems Break (1069); Device Dislodged or Dislocated (2923); Scratched Material (3020)

Patient Problems Corneal Edema (1791); Inflammation (1932); Intraocular Infection (1933); Pain (1994); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

The product was not returned for analysis.The literature report contained photos which did show the broken distal portion of a haptic.The complaint history and product history records could not be reviewed because the reporter did not provide a lot number or any identification traceable to the manufacturing documentation.Associated products were n provided other than a monarch cartridge was used.Without the lens diopter and the specific products used in cannot be determined if a qualified combination was used.The report contained photos of the broken distal end of a single-piece natural haptic.A determination of root cause for the haptic damage could not be made from the photos.The report stated that haptic fragment had a cut appearance.The report suggested that based on a scratch observed adjacent to the damaged haptic, the damage may have been caused by improper manipulation either during the iol loading, or during release of the iol from the plunger or by a defective surgical implantation device.Not enough information was provided in the report to determine if a qualified iol/delivery system combination was used.Company foldable iols are qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported via literature article that two months following a cataract extraction with intraocular lens (iol) implant procedure, the patient began to experience eye irritation, which persisted and worsened over the subsequent months.The patient then began to notice a decrease in vision and the quality of pain became more deep and aching.The patient visited the institution six months after the patient¿s cataract surgery.On initial examination, his best corrected vision was noted to be 20/40 (pinhole to 20/30) in the eye.Slit lamp examination of the eye revealed conjunctival infection and inferior corneal edema extending into the visual axis, inferior descemet¿s folds, and trace cells in the anterior chamber.The iol haptic was noted in the inferior anterior chamber angle lying against the iris and in contact with the corneal endothelium.By ultrasound biomicroscopy, the haptic fragment was located in the inferior angle but did not appear to be contiguous with the remainder of the iol, which was noted to be within the posterior chamber, slightly decentered, with no iris touch.The decision was made to surgically remove the iol fragment and examine the iol position.Intra-operatively, the iol fragment was confirmed to be loose as it shifted position when the patient was supine.The fragment was removed using micro-forceps, and the remainder of the iol was then examined using an endoscope probe.The nasal haptic was noted to be within the capsular bag however, the cut temporal haptic was dislocated out of the capsular bag and fibrosed to the anterior aspect of the anterior capsule.The iol was slightly decentered but stable and therefore was not exchanged.A scratch was also noted on the iol optic in the mid-periphery near the temporal haptic.Post-operatively, the patient¿s corneal edema improved and topical steroids were tapered.At one-month postoperative appointment, patient vision had returned to 20/20 with trace residual inferior corneal edema.The patient has since moved out of state and therefore no long-term follow-up or testing is available.

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE 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 ; 8175514979
• MDR Report Key: 12683992
• MDR Text Key: 278105996
• Report Number: 1119421-2021-01961
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.XXX
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 85 YR