MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. SENSAR IOL; INTRAOCULAR LENS

Model Number UNK-AR40E

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/05/2022

Event Type  malfunction  

Event Description

The following article was received based on literature review.Article: clinical outcomes of transscleral-sutured intraocular lens combined with descemet membrane endothelial keratoplasty a retrospective chart review was done to report clinical outcomes of descemet membrane endothelial keratoplasty (dmek) combined with transscleral-sutured (tss) intraocular lens (iol) (dmek+tss-iol) compared with dmek combined with phacoemulsification and posterior chamber iol (phaco-dmek).Patients with corneal decompensation (n=21 eyes) underwent dmek+tss-iol.The control group had patients with cataract and fuchs endothelial corneal dystrophy (fecd) (n=44 eyes) underwent phaco-dmek.In the dmek-tss-iol group, twelve eyes (n=12 eyes) were implanted with a foldable acrylic 3-piece iol (ar40e).In the control group, all patients (n=44 eyes) received an aspheric single-piece acrylic iol (zcboo).Events in the dmek-tss-iol group included: hyphema (n=1) iol tilt/dislocation (n=1) in the phaco-dmek group, event was pupil block (n=2).There were no further interventions mentioned for these events.Other jnj products were mentioned but no complaints were reported against them.Through follow up, it was learned that all the iols are still implanted in the patient's operative eye.The iol is not in the capsular bag nor in the sulcus, but sutured to the the sclera and those things can happen with this technique.Furthermore, it was reported that the patients had an endothelial corneal transplant at time of surgery and were not considered attributing to the postoperative complications to the iol itself, but to the complex surgery performed.No further information is available.A copy of the article is provided with this report.This report is for incomplete model ar40e malfunction event.Separate reports are being submitted to capture the adverse events for unk ar40e hyphema and unk-zcb00.

Manufacturer Narrative

Section a2: age/date of birth: dmek+tss iol group: 74.45 ± 13.87, phaco-dmek group: 70.70 ± 13.69.Section a4: patient weight: unknown/not provided.Section a5: race/ethnicity: unknown/not provided.Section b3: date of event: 11/05/2022.The date article was accepted.Section d6a: if implanted; give date: unknown/not provided.The lens remains implanted.Section d6b: if explanted; give date: n/a (not applicable).The lens remains implanted.Section d4: model number: a complete model is unknown, as the serial number was not provided.Section d4: catalog number: a complete catalog number is unknown, as the serial number was not provided.Section d4: serial number: unknown, as information was not provided.Section d4: expiration date: unknown, as the serial number was not provided.Section d4: udi number: unknown, as the serial number was not provided.Section h3-other (81): the device was not returned for evaluation as it remains implanted and the serial number for this device is unknown/not provided; therefore, no further product investigation can be performed.Should any further relevant information become available a supplemental medwatch will be filed.Section h4: device manufacture date: unknown, as the serial number was not provided.Section h6: health effect: clinical code: 4581 this code was used for the reported iol tilt/dislocation.Citation: gouvea, l., din, n., alshaker, s., gendler, s., weill, y., chan, c.C., & rootman, d.S.(2023).Clinical outcomes of transscleral-sutured intraocular lens combined with descemet membrane endothelial keratoplasty.Cornea journal, 42(12), pp.1497¿1502.Https://doi.Org/10.1097/ico.0000000000003215.An attempt was made to obtain missing information; however, the author did not have the information.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: SENSAR IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 18858400
• MDR Text Key: 337364775
• Report Number: 3012236936-2024-00592
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK-AR40E
• Device Catalogue Number: UNK-AR40E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1