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

Model Number	PCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Flashers (1864); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth, weight, ethnicity: unknown/not provided.Date of event is unknown.If implanted; give date: unknown, not provided.If explanted; give date: lens remains implanted.The intraocular lens (iol) is not returning for evaluation as it remains implanted; therefore, failure analysis of the complaint device cannot be completed.A review of the device history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The patient had bilateral implants with the tecnis itec preloaded monofocal intraocular lens (iol).She called asking if johnson and johnson knew what the lenses were made of.She then asked if the lenses had been recalled.She reported that she is seeing bouncing lights with her right eye and starbursts in her left eye, even store, and restaurant lights give her starbursts.She has spoken to her doctor about these issues, and they told her to try yellow glasses, and to keep her eyes moisturized.They also gave her lumify eye drops, however she has not tried it yet because she does not want to put another drop in her eyes since she already uses a systaine and a glaucoma drop called xalatan once in both eyes before bed.She stated that right away her left eye fogged up, and they did a capsulotomy, and she can see 20/20 out of it.No further information provided.
Additional Manufacturer Narrative
Additional information was received from duplicate complaint stating patient does see the edge of the left lens when light hits it at a certain angle, but no other visual complaints.Patient also complained that the print on her j&j vision card is too small/hard to read.No further information is available.The following fields were updated accordingly: section h-6 health effect - clinical code: 2140 visual disturbance all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; road 402 north, anasco ind. pk; anasco, PR 00610 ; 7142478552
• MDR Report Key: 11737688
• Report Number: 2648035-2021-07688
• Device Sequence Number: 3527344
• Product Code: HQL
• UDI-Device Identifier: 05050474558120
• UDI-Public: (01)05050474558120(17)230127
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/27/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female