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

Model Number DCB00

Device Problem Physical Resistance/Sticking (4012)

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

Event Type  malfunction  

Event Description

It was reported that the surgeon mentioned the intraocular lens (iol) haptics take too long to open and instruments are needed to open-up the haptics.Through follow up we learned that the lens was implanted.No additional information was received.

Manufacturer Narrative

Section a2, a4 and a5: information unknown/ not provided.Per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section b3 - date of event: unknown/ not provided.Section d4 - catalog number: a complete catalog number is unknown, as product serial number was not provided.Section d4 - serial number: unknown/ not provided.Section d4 - expiration date: unknown, as product serial number was not provided.Section d4 - udi number: unknown, as product serial number was not provided.Section d6a - implant date: unknown/ not provided.Section d6b - explant date: not applicable, as lens remains implanted.Section e1 - email address: unknown/not provided.Section e1 - telephone number: (b)(6).Section h3 - other (81): the intraocular lens (iol) was not returned for evaluation as it remains implanted.The 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.Attempts have been made to obtain the missing information.However, to date, no definitive response has been received.All pertinent information available to johnson and 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: 17076035
• MDR Text Key: 316980202
• Report Number: 3012236936-2023-01327
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DCB00
• Device Catalogue Number: DCB00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/12/2023
• Initial Date FDA Received: 06/06/2023
• 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