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

Model Number UNK_DCB_TECNIS SIMPLICITY PRELOADED 1-PIECE IOL

Device Problems Appropriate Term/Code Not Available (3191); Ejection Problem (4009)

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

Event Type  malfunction  

Event Description

It was reported that doctor feels that as the preloaded intraocular lens(iol) gets towards end of injection, rather than leveling out, lens continues upward towards cornea.Capsule was tenting as the lens is almost fully inserted, rather than staying in line with equator.No patient injury was reported.Instrument was used to reposition lens after injection of iol in the eye.Iol information not available.Iol remains implanted.No further information is provided.

Manufacturer Narrative

Section a2, a4 and a5: unknown/ not provided.Patient information cannot be provided due to personal data privacy legislation/policy section b3: date of event: unknown, not provided.Section d4: catalog number: a complete catalog # 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 e1: email address: unknown/not provided.Section e1: telephone number: unknown, information not provided.Section h3-other (81): the device is not returning for evaluation as to date 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.Section h4: device manufacture date: unknown.An attempt has been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• 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: 18603192
• MDR Text Key: 334806079
• Report Number: 3012236936-2024-00068
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK_DCB_TECNIS SIMPLICITY PRELOADED 1-PIECE IOL
• Device Catalogue Number: UNK-DCB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2024
• 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