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

Model Number PCB00

Device Problems Device Dislodged or Dislocated (2923); Physical Resistance/Sticking (4012)

Patient Problems Macular Edema (1822); Visual Disturbances (2140); Prolapse (2475); Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/17/2020

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: ages are (b)(6).Sex/gender: for this case the gender is provided as both male and female in unknown numbers.Date of event: exact dates not provided, article acceptance date (b)(6), 2020.Serial number : unknown/not provided.Expiration date: unknown as the serial numbers were not provided.Unique identifier (udi) number: unknown as the serial numbers were not provided.Phone : (b)(4).Device manufacture date : unknown as the serial numbers were not provided.The intraocular lens (iol) is not returning for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Stanojcic, n., o¿brart, d., hull, c., wagh, v., azan, e., bhogal, m., robbie, scott., and li, j.O.(2020) visual and refractive outcomes and glistening occurrence after implantation of 2 hydrophobic acrylic aspheric monofocal iols, journal of cataract & refractive surgery, 46(7), pp.986-994 https://doi.Org/10.1097/j.Jcrs.0000000000000201 all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

The following article was received based on a literature review: article: visual and refractive outcomes and glistenings occurrence after implantation of 2 hydrophobic acrylic aspheric monofocal iols.A prospective, single-center randomized controlled trial was done to compare the clareon intraocular lens (iol) with the tecnis pcb00 iol (johnson & johnson vision) in terms of visual performance, refractive outcomes, glistenings occurrence, and quality-of-life outcomes.Sixty eight patients (136 eyes) were randomized to the tecnis iol group.Perioperative complications occurred in the tecnis iol group include iris trauma/prolapse (n=1), retained cortical matter (n=1), angle trauma (n=1), stuck haptics (n=1), malpositioned haptics (n=1), and posterior capsule rupture (n=1).Post-operative complications occurred in the tecnis iol group include posterior capsular opacification (pco) (n=9 eyes), negative dysphotopsia (n=2 eyes), and cystoid macular edema (cme) (n=11 eyes).In addition, one (n=1) tecnis pcb00 iol developed grade 1 glistenings (between 1 and 10 glistenings/mm2).At 12 months, the mean manifest refraction spherical equivalent (se) error (d) was 0.02 ± 0.3; the mean absolute se refractive error from target refraction (d) was 0.25 ± 0.20; and the residual refractive cylinder was -0.74 ± 0.47 for the tecnis pcb00 iol group.Of the 9 eyes with pco, 2 eyes required nd:yag capsulotomy.Further interventions for the reported complications were not specified in the study.This report is to capture the reported adverse events.A separate report is being submitted for the reported product problems.

Manufacturer Narrative

Corrected data: section h6: as part of an internal review of our mdrs it was identified that the following codes should not have been indicated in the initial report.2923 - device dislodged or dislocated, 4012 - physical resistance/sticking.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS 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 ; road 402 north, anasco ind. pk; anasco, PR 00610 ; 7142478552
• MDR Report Key: 11369886
• MDR Text Key: 240648228
• Report Number: 2648035-2021-07267
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PCB00
• Device Catalogue Number: UNK-PCB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2022
• 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
• Patient Outcome(s): Required Intervention