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

Model Number ZCB00

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Visual Disturbances (2140)

Event Type  malfunction  

Manufacturer Narrative

Section a2: age/date of birth (years): ages are 62.09 ± 8.64 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, article acceptance date is (b)(6) 2022 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: brar s, vanga hr, shah ml, ganesh s.A prospective, randomized, comparative clinical study to compare the safety and efficacy of di¿erent hydrophobic aspheric monofocal intraocular lenses.Indian j ophthalmol 2023;71 :771-8.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

Literature title: a prospective, randomized, comparative clinical study to compare the safety and efficacy of different hydrophobic aspheric monofocal intraocular lenses a prospective randomized study was done to report the 1-year clinical outcomes related to safety, efficacy, predictability, contrast sensitivity, patient satisfaction, complications, and overall results with optiflex genesis and eyecryl plus (ashfy 600) monofocal aspheric intraocular lenses (iols) and compare the same with tecnis-1 monofocal iol.A total of 159 eyes of 140 eligible patients underwent cataract extraction with iol implantation with any of the three study lenses.Out of 159 eyes, 53 eyes were implanted with the tecnis-1 monofocal iol.In patients implanted with the tecnis-1 monofocal iol, the following were reported as mean ± standard deviation at one-year post-op: the internal higher order aberration (hoa) was found to be at -0.271±0.12mm, internal spherical aberration (sa) was at -0.261±0.02mm, internal coma was at -0.062±0.04mm, whole eye hoa was at 0.105±0.05mm, and whole eye sa was -0.008±0.02mm.It was also reported that 7 eyes in the tecnis group had optic haptic adhesions requiring separation with a sinskey¿s hook.A copy of the article is provided with this report.

• 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 ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 18833313
• MDR Text Key: 337306401
• Report Number: 3012236936-2024-00555
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZCB00
• Device Catalogue Number: UNK-ZCB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2024
• 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