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

Model Number AAB00

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Eye Injury (1845); Visual Impairment (2138); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/14/2021

Event Type  Injury  

Manufacturer Narrative

Additional information: age and birth date, patient weight, and ethnicity and race: unknown as information was not provided.Device serial number: unknown as information was not provided.Device expiration date: unknown as device serial number was not provided.Device unique identifier (udi) number: udi number is unknown as device serial number was not provided.Date implanted: unknown as information was not provided.Device manufacture date: unknown as device serial number was not provided.(b)(4).Device evaluation: product evaluation could not be performed since the device was discarded.Therefore, the reported issue could not be verified.Manufacturing records review: the manufacturing record cannot be reviewed since the iol serial number is unknown.Historical data analysis: the complaint history was not reviewed since the iol serial number is unknown.Conclusion: as a result of the investigation, there is no indication of a product malfunction or product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported the intraocular lens (iol) was implanted in the patient's operative eye.The iol was explanted due to complaints of refractive miss and ended up -2.0.During the iol exchange procedure the doctor realized that the original iol had one (01) haptic that was out of the bag and therefore the iol was more anterior.Also, because it was a few months after the original lens implant the anterior and posterior surface of the bag in the area where the haptic was out of the bag had fused together.The doctor could not reposition or place a lens in the bag.As a result the doctor implanted a different model iol (za9003) with a lower diopter size (21.5 d).Post operatively it was reported that the patient has some edema but the doctor expects it to clear and that they will be much closer now to plano.The explanted lens was not saved.No further information is available.

• Brand Name: SENSAR 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 ; road 402 north, anasco ind. pk; anasco, PR 00610 ; 7142478552
• MDR Report Key: 11995442
• MDR Text Key: 263417472
• Report Number: 2648035-2021-07915
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2021
• 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
• Patient Outcome(s): Required Intervention