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

Model Number ZCT

Device Problem Unstable (1667)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Literature title: comparison of capsular tension ring implantation before vs.After toric intraocular lens for rotational stability a randomized retrospective study was done to compare the effect of implanting the capsular tension ring (ctr) before or after a toric intraocular lens (iol) on rotational stability in patients with cataract and astigmatism.A total of 108 eyes of 108 patients underwent phacoemulsification combined with toric iol implantation due to cataract and astigmatism.The patients were divided into two groups: group 1 consisted of 53 eyes of 53 patients in whom the ctr was placed into the capsular bag after the implantation of the toric iol and group 2 consisted of 55 eyes of 55 patients in whom the ctr was placed into the capsular bag before implantation of the toric iol.Tecnis toric iol (13mm haptic diamaters, tecnis toric zct, johnson & johnson vision) and 13mm sized ctr (130ao, hoya) were implanted in the eyes of all patients.In group 1, only 10 degrees of rotation was observed in 4 eyes while the toric iol rotation in group 2 was 30 degrees in 1 eye, 20 degrees in 3 eyes, and 10 degrees in 7 eyes.The mean degree of rotation was 0.75 ± 2.66 degrees in group 1 and 2.90 ± 6.57 degrees in group 2.There are no indications in the article of any interventions provided.A copy of the article is provided with this report.Note: this report is for group 2.A separate report will be submitted for the other group.

Manufacturer Narrative

Section a2: mean age 57.23 ± 8.08 section a3: 27 male (49%) and 28 female (51%) sections a4, a5: information unknown/not provided.Section b3: date of event: exact dates not provided.Article acceptance date is october 12th, 2022.The study was conducted for surgeries performed between february 2018 and october 2019.Section d4: model number: complete number is unknown, as the serial number was not provided.Section d4: catalog number: complete number is unknown, as the serial number was not provided.Section d4: serial number: unknown, information 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 d6a - implant date: unknown/ not provided section d6b - explant date: n/a, lens remains implanted.Section h3 - other (81): the implants were not returned for evaluation as they remain implanted.Therefore, a failure analysis of the complaint device could not 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 and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.Section h4: device manufacture date: unknown, as the serial number was not provided.Citation: s.Cetinkaya; f ucar; comparison of capsular tension ring implantation before vs.After toric intraocular lens for rotational stability; october 12th, 2022, klin.Monatsbl.Augenheilk.2023; 240:1-6; doi 10.1055/a-1964-7552 all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 18794024
• MDR Text Key: 337516990
• Report Number: 3012236936-2024-00435
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZCT
• Device Catalogue Number: UNK-ZCT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2024
• 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