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

Model Number ZCT

Device Problem Unstable (1667)

Patient Problems Capsular Contracture (1761); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Manufacturer Narrative

Section a2: age/date of birth (years): ages are 72.04 8.34.Section a3: sex/gender: (male: female): unknown, not provided.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: yiyi wang, md; xicong lou, md; shuyi qian, md; yuanyuan li, md; xueer wu, md; siyan li phd; yalan wang, md; yune zhao, md; pingjun chang, md, comparison of the effect of capsular bend on the rotational stability between two toric intraocular lenses, (2023), ascrs and escrs; issue & volume: pp.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

Literature title: comparison of the effect of capsular bend on the rotational stability between two toric intraocular lenses.A prospective study was done to compare the effect of capsular bend on the rotational stability between two toric intraocular lenses (iols).A total of 58 eyes of 58 patients with pre-existing astigmatism received acrysof iq sn6at3 - t8 (n=29 eyes) or tecnis zct/zmt 150-400 (n=29 eyes) toric iol during cataract surgery.It was reported that the tecnis zct/zmt group was reported to have a total misalignment of 6.86 5.27 degrees, a mean rotation of 2.66 2.18 degrees, a capsular bend index (cbi) value of 3.49 0.46, an iol tilt of 4.75 1.18 degrees and an iol decentration at 0.17 0.01mm at 3-months post-op.The tecnis(zct/zmt) group was also reported to show fibrosis in the peripheral anterior capsule, leading to its stretching away from the iol surface.There are no indications in the article of any interventions provided.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: 18908324
• MDR Text Key: 337748871
• Report Number: 3012236936-2024-00561
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• 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: 02/20/2024
• 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