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

Model Number ZCT300

Device Problem Unstable (1667)

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

Event Type  malfunction  

Manufacturer Narrative

Section a2: age/date of birth (years): ages are 69.6 ± 8.7 section a3: sex/gender: (male: female): 19:20.Section a4 & a5: information unknown, not provided.Section b3: date of event: exact dates not provided.Section d4: a complete catalog 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: a complete udi number is unknown, as the serial number was not provided.Section d6a: implant date: unknown, information not provided.Section d6b: explant date: not applicable, as lens was not explanted.Section h3-other (81): the device was not returned for analysis.The serial lot/serial number for this device is not available; therefore, no further investigation can be performed.If there is any further relevant information received, a supplemental medwatch will be filed.Section h4: device manufacture date: unknown, as the serial number was not provided.Citation: hu dongrui, li qi, jin ganying, zeng qinsen, determination and evaluation of efficacy and rotational stability of two toric intraocular lenses, (2023), chinese journal of experimental ophthalmology; vol.41, no.12: 1187 to 1195 all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

Literature title: determination and evaluation of efficacy and rotational stability of two toric intraocular lenses.A cohort study was done to objectively evaluate the postoperative efficacy and rotational stability of two common types of toric intraocular lenses (iols), and perform vector analysis of postoperative residual astigmatism.A total of 80 eyes of 80 patients with age-related cataract combined with regular corneal astigmatism underwent phacoemulsification combined with toric iol implantation with either the tecnis zct iol (zct150 to zct400; johnson & johnson vision) (n=39 eyes) or the acrysof iq toric iol (sn6at4 to sn6at6; alcon) (n=41 eyes).At 3-months post-op, it was reported that the percentage of eyes with deviation of lens axis (lad) of = 5 degrees was 71.8% (n=28 eyes) and the percentage of eyes with lad of = 10 degrees was 94.9% (n=37 eyes) in the tecnis group.It was also reported that there were two cases in the tecnis group with an lad of 12°, but no surgical repositioning was performed.A copy of the article is provided with this report.

• 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: 18918447
• MDR Text Key: 337850313
• Report Number: 3012236936-2024-00564
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZCT300
• 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: 02/22/2024
• Was Device Evaluated by Manufacturer?: No
• 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